비타민B6 (피리독신)
Vitamin B6 (Pyridoxine)
📚 관련 논문 (23편)
1. J Inorg Biochem. 1992 Apr;46(1):17-22. doi: 10.1016/0162-0134(92)80059-5. Chemical and in vivo studies of interaction between cadmium and vitamin B6. Couce MD(1), Varela JM, Sánchez A, Casas JS, Sordo J, López-Rivadulla M. Author information: (1)Departamento de Química Inorgánica, Facultad de
2. BMJ Clin Evid. 2015 May 13;2015:1113. Leg cramps. Young G(1). Author information: (1)Temple Sowerby Medical Practice, Penrith, UK. INTRODUCTION: Involuntary, localised leg cramps are common and typically affect the calf muscles at night. METHODS AND OUTCOMES: We conducted a systematic review
3. Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD000145. doi: 10.1002/14651858.CD000145.pub2. WITHDRAWN: Interventions for nausea and vomiting in early pregnancy. Jewell D(1), Young G. Author information: (1)Division of Primary Health Care, University of Bristol, Cotham House, Cotham Hill, B
4. BMJ Clin Evid. 2010 Jan 7;2010:0322. Autism. Parr J(1). Author information: (1)Newcastle University, Newcastle Upon Tyne, UK. INTRODUCTION: Evidence for the efficacy of treatments for autism has improved in recent years. In this systematic review the evidence for both drug and non-drug trea
5. Cochrane Database Syst Rev. 2003;(4):CD004393. doi: 10.1002/14651858.CD004393. The effect of vitamin B6 on cognition. Malouf R(1), Grimley Evans J. Author information: (1)Dept. of Clinical Geratology, Cochrane Dementia and Cognitive Improvement Group, Radcliffe Infirmary, Woodstock Road, Oxfo
6. Cochrane Database Syst Rev. 2003;(4):CD000145. doi: 10.1002/14651858.CD000145. Interventions for nausea and vomiting in early pregnancy. Jewell D(1), Young G. Author information: (1)Division of Primary Health Care, University of Bristol, Cotham House, Cotham Hill, Bristol, UK, BS6 6JL. david.
7. Cochrane Database Syst Rev. 2002;(1):CD000145. doi: 10.1002/14651858.CD000145. Interventions for nausea and vomiting in early pregnancy. Jewell D(1), Young G. Author information: (1)Division of Primary Health Care, University of Bristol, Canynge Hall, Whiteladies Road, Bristol, UK. david.jewe
8. Cochrane Database Syst Rev. 2000;(2):CD000145. doi: 10.1002/14651858.CD000145. Interventions for nausea and vomiting in early pregnancy. Jewell D(1), Young G. Author information: (1)Division of Primary Health Care, University of Bristol, Canynge Hall, Whiteladies Road, Bristol, UK. david.jewe
1. Nutrients. 2026 Mar 5;18(5):842. doi: 10.3390/nu18050842. Complex Effects of B-Vitamin Combinations on Cardiovascular Diseases: A Systematic Review and Meta-Analysis of Randomized Controlled Trials over Three Decades. Ren R(1), Yang A(2), Chow A(3), Wang K(4), Wang S(5), Leo C(6), Lu Y(7)(8), Li M(9). Author information: (1)College of Pharmacy, University of Minnesota, Minneapolis, MN 55415, USA. (2)Dartmouth College, Hanover, NH 03755, USA. (3)College of Arts and Science, New York University, New York, NY 10012, USA. (4)University of Washington School of Medicine, 1959 NE Pacific St., Seattle, WA 98195, USA. (5)NYU Langone Hospital-Long Island, Mineola, NY 11501, USA. (6)Duke Raleigh Hospital, a Campus of Duke University Hospital, School of Medicine, Duke University, Durham, NC 27708, USA. (7)College of Pharmacy, University of Minnesota, Hennepin Healthcare System, Minneapolis, MN 55415, USA. (8)Department of Pharmacy, Hennepin Healthcare System, Minneapolis, MN 55415, USA. (9)Brigham and Women's Hospital, Boston, MA 02115, USA. Background and Purpose: The effects of B-vitamin combinations on the prevention of cardiovascular diseases, such as myocardial infarction (MI) and stroke, remain controversial. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) over three decades to evaluate the association between B-vitamin combinations and mortality and arterial thrombotic outcomes. Methods: PubMed, Embase, Web of Science, and the Cochrane Library were systematically searched for RCTs with minimal duration over 24 months published between January 1996 and November 2025. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2.0 tool. Random-effects models were used in this meta-analysis to calculate pooled risk ratios (RRs) and 95% confidence intervals (CIs). Results: Thirteen randomized trials enrolling 68,363 participants across both primary and secondary prevention populations were included. B-vitamin combinations were associated with a nonsignificant reduction in stroke and 3-point major adverse cardiovascular events (MACE) (stroke: RR 0.91, 95% CI 0.81-1.04; MACE: RR 0.93, 95% CI 0.86-1.01). No significant effects were observed for all-cause mortality (RR 1.01, 95% CI 0.96-1.06), cardiovascular mortality (RR 0.97, 95% CI 0.88-1.07), or MI (RR 0.97, 95% CI 0.91-1.03). In primary prevention populations, B-vitamin combinations were associated with significant reductions in stroke (RR 0.79, 95% CI 0.68-0.93) and MACE (RR 0.80, 95% CI 0.69-0.92). A modest reduction in MACE was also observed in secondary prevention populations (RR 0.91, 95% CI 0.83-0.99). Between-study heterogeneity was minimal to low for ischemic outcomes, supporting the robustness of these estimates, whereas substantial heterogeneity was observed for mortality outcomes in secondary prevention populations. Conclusions: The evidence is limited by heterogeneity in trial populations, vitamin formulations and doses, and outcome definitions, with substantial between-study inconsistency for mortality outcomes and imprecision in subgroup estimates derived from a small number of contributing trials. Overall, B-vitamin combinations do not confer consistent benefit for major cardiovascular outcomes but may reduce stroke and MACE in selected primary prevention populations, suggesting that baseline cardiovascular risk and regional folic acid fortification modify treatment effects and should guide future trial design and clinical use. DOI: 10.3390/nu18050842 PMCID: PMC12986992 PMID: 41830012 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.
2. Ann Med. 2026 Dec;58(1):2622208. doi: 10.1080/07853890.2026.2622208. Epub 2026 Jan 30. Combined B-vitamin supplementation on homocysteine and vascular outcomes in coronary heart disease: a meta-analysis. Guo L(1), Shi X(2), Wang G(3), Han W(1), Ding R(1), Wang S(4), Yuan D(3). Author information: (1)Department of Pharmacy, The 7th People's Hospital of Zhengzhou, Zhengzhou, Henan Province, People's Republic of China. (2)Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China. (3)Clinical Trial Institution for Drugs, The 7th People's Hospital of Zhengzhou, Zhengzhou, Henan Province, People's Republic of China. (4)School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China. OBJECTIVE: Hyperhomocysteinemia (Hcy) independently predicts coronary heart disease (CHD) and adverse cardiovascular events. Although folic acid plays a key role in Hcy metabolism, the effect of combined B-vitamin supplementation (folic acid, VB6, and VB12) on clinical outcomes in CHD remains uncertain. METHODS: A systematic search of PubMed, Embase, and the Cochrane Library was conducted from inception through April 2025 using MeSH terms including "folic acid," "vitamin B6," "vitamin B12," "coronary heart disease," and "homocysteine." A random-effects model was used for meta-analysis. RESULTS: Thirteen studies involving 14,539 participants were included in the meta-analysis (7,338 patients treated with folic acid combined with vitamin B complex and 7,301 controls). Combined B-vitamin supplementation significantly reduced serum Hcy levels [mean difference: -2.36; 95% confidence interval (CI): (-3.09 to -1.62); p < 0.01] compared with any single-nutrient regimen. The incidence of vascular restenosis was lower in the intervention group than in the control group (risk ratio: 0.65; 95% CI: 0.44-0.95; p < 0.05). However, no significant differences were observed in the incidence of major cardiovascular events (p = 0.78) or cardiovascular-related mortality (risk ratio: 0.96; 95% CI: 0.85-1.07; p = 0.44). CONCLUSION: Combined B-vitamin supplementation effectively lowers serum Hcy levels and the incidence of vascular restenosis in patients with CHD. However, its impact on cardiovascular events and mortality remains inconclusive. Plain Language Summary: Meta-analysis of 13 RCTs (n = 14,539): combined B vitamins lower serum HcyCombined B-vitamin supplementation lowers vascular restenosis in CHD patientsExerts no significant impact on major CV events or mortalityHcy-lowering appears CHD-specific; broader CV benefits remain unproven. DOI: 10.1080/07853890.2026.2622208 PMCID: PMC12862861 PMID: 41615824 [Indexed for MEDLINE] Conflict of interest statement: No potential conflict of interest was reported by the author(s).
3. Nutr Metab Cardiovasc Dis. 2026 Mar;36(3):104470. doi: 10.1016/j.numecd.2025.104470. Epub 2025 Nov 14. Improved HDL, LDL and total cholesterol levels following a 3-month administration of Mentha spicata leaf extract and Amaranthus caudatus seed flour extracts, flavonoids and B vitamins. A placebo-controlled, double-blind, randomized clinical trial. Di Minno A(1), Morone MV(2), Cordara M(3), Buccato DG(2), De Lellis LF(2), Ullah H(4), Piccinocchi R(5), Larsen DS(6), Baldi A(2), Piccinocchi G(7), Xiao X(8), Sacchi R(9), Daglia M(10). Author information: (1)Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131, Naples, Italy; CEINGE-Biotecnologie Avanzate, Via Gaetano Salvatore 486, 80145, Naples, Italy. (2)Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131, Naples, Italy. (3)School of Medicine, University of Milano-Bicocca, 20126, Milan, Italy. (4)School of Pharmacy, University of Management and Technology, Lahore, 54000, Pakistan. Electronic address: hammadrph@gmail.com. (5)Anaesthesia and Resuscitation A. U. O. Luigi Vanvitelli, Via Santa Maria di Costantinopoli, 80138, Naples, Italy. (6)School of Chemical Sciences, The University of Auckland, Auckland, 1010, New Zealand. (7)Comegen S.C.S., Società Cooperativa Sociale, Viale Maria Bakunin 41, 80125, Naples, Italy. (8)School of Food and Biological Engineering, Jiangsu University, Zhenjiang, 212013, China. (9)Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, Viale Taramelli 24, 27100, Pavia, Italy. (10)Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131, Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang, 212013, China. Electronic address: maria.daglia@unina.it. BACKGROUND AND AIMS: We have evaluated the efficacy and tolerability of two food supplements (FS) containing flavonoids (naringin and hesperidin); same doses of B3, B6, B9 and B12 vitamins, and two different doses of a blend of Mentha spicata leaf extract and Amaranthus caudatus seed flour, in subjects with borderline high total (TC) and low-density lipoprotein cholesterol (LDL-C) levels. METHODS AND RESULTS: 114 Participants (18-70 years) with TC levels 200-239 mg/dL, (5.18-6.19 mmol/L) and LDL-C (<159 mg/dL) were randomised into three groups to receive for 90 days the lowest (n = 38, Treatment A), the highest dose of the FS (n = 38 - Treatment B), or placebo (n = 38). Treatment B was associated with a significant reduction in LDL-C (∼31.5 mg/dL;-22%) and TC (∼19.5 mg/dL; -9%), along with an increase in high-density lipoprotein cholesterol (HDL-C). The greater efficacy of Treatment B containing the highest dose of vegetable extracts is likely attributable to its higher M. spicata extract content, as judged by high-resolution mass spectrometry analysis of the preparation. CONCLUSION: The combination of different FS ingredients with different mechanisms of action can be a valuable strategy for improving lipid profiles in subjects with borderline high TC and LDL-C levels. Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved. DOI: 10.1016/j.numecd.2025.104470 PMID: 41519619 [Indexed for MEDLINE]
4. Sci Rep. 2025 Nov 28;15(1):42799. doi: 10.1038/s41598-025-26975-1. Effects of bromelain supplementation on disease activity and quality of life in patients with ulcerative colitis: a randomized, triple-blind, placebo-controlled study. Delgarm P(1), Mokhtare M(2), Ebrahimi Daryani N(3), Abolghasemi J(4), Rahideh ST(5). Author information: (1)Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. (2)Gastroenterology and Hepatology, Internal Medicine Department, Iran University of Medical Sciences, Tehran, Iran. (3)Department of Gastroenterology and Hepatology, Tehran University of Medical Sciences, Tehran, Iran. (4)Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. (5)Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. rahide.t@iums.ac.ir. Bromelain is a proteolytic enzyme found in pineapple fruit. This study was conducted to evaluate the effects of bromelain supplementation on disease activity and quality of life (QoL) in patients with ulcerative colitis (UC). Seventy individuals with mild-to-moderate UC participated in a randomized, triple-blind clinical trial. Participants were randomly assigned to receive either maltodextrin as a placebo or 400 mg of bromelain daily for eight weeks. QoL and Simple Clinical Colitis Activity Index (SCCAI) scores were assessed. All results were analyzed using both intention-to-treat (ITT) and per-protocol (PP) approaches. The only demographic factor that differed between the two groups statistically significantly was gender (p = 0.01). Additionally, the mean difference in vitamin B6 consumption variations between the bromelain and placebo groups was significant (0.39 ± 0.86 vs. -0.44 ± 1.43; p < 0.001). There was no considerable difference detected for the other nutrients. The bromelain group had considerably higher changes in their SCCAI score in comparison with the placebo group (-3.29 ± 2.17 vs. -1.11 ± 1.71; p < 0.001). There was no considerable difference in changes in QoL questionnaire scores between the intervention and control groups (3.76 ± 6.18 vs. 3.91 ± 4.30; p = 0.90). After correcting for baseline, the findings remained significant for the SCCAI variable but not for the QoL variable (p < 0.001 and p = 0.99). In UC patients, the severity of the disease is reduced by bromelain supplementation, which is an alternative therapy.Trial registration: The study protocol received approval from the Ethics Committee at Iran University of Medical Sciences "IR.IUMS.REC.1402.125" and was registered with the Iranian Clinical Trials Registry "IRCT20191105045340N2" on 09/07/2023. © 2025. The Author(s). DOI: 10.1038/s41598-025-26975-1 PMCID: PMC12663318 PMID: 41315628 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Competing interests: The authors declare no competing interests.
5. Trials. 2025 Oct 13;26(1):403. doi: 10.1186/s13063-025-09168-z. Interventional Vitamin Mix Glaucoma Study (IVMGS): study protocol for a prospective, randomized, two-arm, single-center trial in existing glaucoma patients. Golpour N(1), Hui F(2), Nilsson M(1), Svensson J(3), Brautaset RL(#)(4), Tribble JR(#)(5), Williams PA(#)(6). Author information: (1)Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. (2)Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia. (3)Department of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden. (4)Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. rune.brautaset@ki.se. (5)Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. james.tribble@ki.se. (6)Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. pete.williams@ki.se. (#)Contributed equally BACKGROUND: Glaucoma is a leading cause of irreversible blindness, characterized by progressive degeneration of retinal ganglion cells. Current treatments primarily lower intraocular pressure but do not directly provide neuroprotection. Preclinical studies from our group have identified dysfunction in one-carbon metabolism as a contributor to glaucomatous neurodegeneration in rodent models. The Interventional Vitamin Mix Glaucoma Study will evaluate whether 12 months of supplementation with key one-carbon metabolism cofactors and precursors (vitamins B6, B9, B12, and choline) can improve inner retinal function and provide neuroprotection compared with standard care alone. METHODS: The Interventional Vitamin Mix Glaucoma Study is a Phase 2a, open-label, randomized, two-arm clinical trial. Participants will be assigned in a one-to-one ratio to receive either daily one-carbon metabolism supplementation plus standard care or standard care alone. The study will enroll 80 patients with primary open-angle glaucoma, normal tension glaucoma, or pseudoexfoliation glaucoma, each with mild-to-moderate visual field loss in at least one eye. Recruitment will take place from March 2025 to March 2026 at St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. The primary outcome is change in the photopic negative response measured by full-field electroretinography. Secondary outcomes include changes in visual field parameters, retinal nerve fiber layer thickness, and ganglion cell-inner plexiform layer thickness. Exploratory outcomes will include changes in blood-based metabolomic and DNA methylation profiles. DISCUSSION: One-carbon metabolism-based supplementation has been shown to reduce retinal ganglion cell loss in rodent models of glaucoma. This trial will investigate whether such supplementation improves retinal function and confers neuroprotection in patients with glaucoma. The use of full-field electroretinography as the primary outcome aims to detect early functional improvements in the retina. If successful, this approach could support a low-cost, widely available neuroprotective strategy to be used alongside existing intraocular pressure-lowering therapies. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov (NCT06885827), first posted on 20 March 2025. © 2025. The Author(s). DOI: 10.1186/s13063-025-09168-z PMCID: PMC12516856 PMID: 41084053 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate {24}: The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the Swedish Ethical Review Authority (reference number: 2024–00838–02) on February 6, 2024. The trial is registered at ClinicalTrials.gov (NCT06885827). Written, informed consent to participate will be obtained from all participants before any study procedures. Consent for publication {32}: No individual, identifiable personal data will be published from this trial. All participants provide written informed consent for participation in the study, including consent for use of de-identified data in scientific publications. The full participant information sheet and consent form, available in Swedish, is included as supplementary file 1. Competing interests {28}: The authors declare that they have no competing interests.
6. JAMA Netw Open. 2025 Sep 2;8(9):e2532405. doi: 10.1001/jamanetworkopen.2025.32405. Antioxidant Treatment and the Chance to Conceive in Men Seeking Fertility Care: The SUMMER Randomized Clinical Trial. de Ligny WR(1)(2), de Bruin JP(2), Smits RM(1), Goovaerts IGF(3), Peeters K(3), Nap AW(1), Boxmeer JC(4), Donker RB(5), Schoonenberg M(6), Koks CAM(7), van Rumste MME(8), Visser J(9), Gielen SCJP(10), Boomsma CM(11), Smeenk JMJ(12), van Oppenraaij RHF(13), Cox T(14), Janse F(15), Muller LT(16), Brink-van der Vlugt JJ(17), Braat DDM(1), Fleischer K(6). Author information: (1)Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, the Netherlands. (2)Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands. (3)Center of Reproductive Medicine, Antwerp University Hospital, Edegem, Belgium. (4)Center of Reproductive Medicine, Voorburg Reinier de Graaf, Voorburg, the Netherlands. (5)Department of Obstetrics and Gynecology, Slingeland Hospital, Doetinchem, the Netherlands. (6)Nij Geertgen Center for Reproductive Medicine, Elsendorp, the Netherlands. (7)Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands. (8)Department of Obstetrics and Gynecology, Catharina Hospital, Eindhoven, the Netherlands. (9)Department of Obstetrics and Gynecology, Amphia Hospital, Breda, the Netherlands. (10)Department of Obstetrics and Gynecology, Franciscus Hospital, Rotterdam, the Netherlands. (11)Department of Obstetrics and Gynecology, Bravis Hospital, Roosendaal, the Netherlands. (12)Department of Obstetrics and Gynecology, Elisabeth TweeSteden Hospital, Tilburg, the Netherlands. (13)Department of Obstetrics and Gynecology, Maasstad Hospital, Rotterdam, the Netherlands. (14)Department of Obstetrics and Gynecology, Medisch Centrum Kinderwens, Leiderdorp, the Netherlands. (15)Department of Obstetrics and Gynecology, Rjinstate Hospital, Arnhem, the Netherlands. (16)Department of Obstetrics and Gynecology, Bernhoven Hospital, Uden, the Netherlands. (17)Nij Barrahûs Center for Reproductive Medicine, Wolvega, the Netherlands. IMPORTANCE: Treatments for men seeking fertility care are limited. Antioxidant supplements have been widely studied as a new treatment option, but these studies have had conflicting results. OBJECTIVE: To assess whether treatment of men seeking fertility care with an antioxidant supplement can improve semen quality and pregnancy rates compared with a placebo. DESIGN, SETTING, AND PARTICIPANTS: The SUMMER trial was a multicenter, double-blind, placebo-controlled randomized clinical trial conducted in 21 hospitals and private fertility clinics in the Netherlands. Male patients in these centers were enrolled between May 2018 and February 2024, and follow-up of the primary outcome was completed in December 2024. Eligible participants were men aged 18 to 50 years with female partners aged 18 to 43 years, who sought fertility care and were advised to undergo expectant management, treatment with intrauterine insemination, in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI). Couples treated with ovulation induction only or IVF for bilateral tubal pathology were excluded. The men were randomly assigned to receive an antioxidant supplement or a placebo. Intention-to-treat analysis was performed for all outcomes. INTERVENTIONS: The antioxidant supplement (Impryl) was a tablet to be taken daily for 6 months. It contained betaine (200 mg), L-cystine (200 mg), niacin (16 mg), zinc (10 mg), vitamin B6 (1.4 mg), vitamin B2 (1.4 mg), folic acid (400 µg), and vitamin B12 (2.5 µg). The placebo tablet and its packaging were identical to those of the antioxidant supplement. All participating couples received standard infertility care. MAIN OUTCOMES AND MEASURES: The primary outcome was ongoing pregnancy conceived within 6 months after randomization. Secondary outcomes included semen parameters, sperm DNA fragmentation, fertilization and embryo utilization rates after IVF or ICSI, biochemical and clinical pregnancy rates, first-trimester pregnancy loss, ectopic pregnancy rate, cumulative number of pregnancies, time to pregnancy, and adverse events. RESULTS: A total of 1171 men (median [IQR] age, 34 [31-38] years; female partners' median [IQR] age, 32 [30-35] years) were included in the data analysis, of whom 591 were in the antioxidant supplement group and 580 were in the placebo group. Ongoing pregnancy rate within 6 months was not significantly different between the 2 groups (193 of 571 [33.8%] vs 208 of 555 [37.5%]; adjusted odds ratio [AOR], 0.85 [95% CI, 0.66-1.09]; P = .20). Within the window of optimal treatment effect between 4 and 6 months (considering a spermatogenesis cycle of 72 days), ongoing pregnancy rate was significantly lower in the antioxidant supplement group compared with the placebo group (69 of 446 [15.5%] vs 95 of 442 [21.5%]; AOR, 0.66 [95% CI, 0.47-0.94]; P = .02). There were no significant between-group differences for the secondary outcomes. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that ongoing pregnancy rates did not improve with the antioxidant supplement compared with a placebo. Therefore, the investigators do not support its use in men seeking fertility care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03337360. DOI: 10.1001/jamanetworkopen.2025.32405 PMCID: PMC12464787 PMID: 40996763 [Indexed for MEDLINE] Conflict of interest statement: Conflict of Interest Disclosures: Dr de Ligny reported receiving an unrestricted research grant and study medications from Goodlife Pharma BV during the conduct of the study and educational support from Ferring outside the submitted work. Dr de Bruin reported receiving an unrestricted research grant from Goodlife Pharma BV during the conduct of the study. Dr Smits reported receiving an unrestricted research grant from Goodlife Pharma BV during the conduct of the study. Dr van Rumste reported receiving personal fees from Ferring BV and Merck Group outside the submitted work. Dr Smeenk reported receiving grants from Merck BV, Ferring BV, and Goodlife Pharma BV outside the submitted work. Dr Fleischer reported receiving an unrestricted research grant from Goodlife Pharma BV during the conduct of the study. No other disclosures were reported.
7. Nutr Rev. 2025 Dec 1;83(12):2256-2267. doi: 10.1093/nutrit/nuaf155. Efficacy of B Vitamin Supplementation on Global Cognitive Function in Older Adults: A Systematic Review and Meta-analysis. Berg J(1)(2), Grant R(2), Siervo M(3)(4)(5), Stephan BCM(3), Tully PJ(6)(7). Author information: (1)School of Psychology, University of New England, Armidale, New South Wales 2350, Australia. (2)Centre for Lifestyle Medicine and Health, Avondale University, Cooranbong, New South Wales 2265, Australia. (3)Dementia Centre of Excellence, enAble Institute, Faculty of Health Sciences, Curtin University, Bentley, Western Australia 6102, Australia. (4)Curtin School of Population Health, Faculty of Health Sciences, Curtin University, Bentley, Western Australia 6102, Australia. (5)Curtin Medical Research Institute (CMRI), Curtin University, Bentley, Western Australia 6102, Australia. (6)School of Medicine, University of Adelaide, Adelaide, South Australia 5005, Australia. (7)School of Psychology, Deakin University, Burwood, Victoria 3125, Australia. CONTEXT: Elevated homocysteine levels are associated with brain atrophy and dementia, with B vitamin supplementation a possible low-cost intervention to help mitigate the deleterious impacts on brain health. However, prior meta-analyses have produced inconsistent results, with unexplained heterogeneity, while the quality of evidence has not been assessed. OBJECTIVE: This systematic review, meta-analysis, and meta-regression sought to quantify the effect of B vitamin supplementation on global cognitive function in older adults. DATA SOURCES: PubMed, Embase, PsychInfo, Scopus, and the Cochrane Library databases were searched for randomized controlled trials (RCTs) from inception to June 20, 2024. DATA EXTRACTION: Eligible RCTs were derived from populations aged ≥60 years, with interventions of 26 weeks or longer comprising vitamin(s) B6, B9, or B12 of any dose or administration route, compared with placebo or usual dementia care. Studies must also have quantified global cognitive function at baseline and at end of treatment. DATA ANALYSIS: Seventeen RCTs, including 5275 participants, were identified. A small to moderate improvement (Hedges' g = 0.423; 95% CI: 0.188 to 0.657) in global cognitive function after supplementation was observed with considerable heterogeneity (I2 = 92.71; Grading of Recommendations, Assessment, Development, and Evaluations [GRADE] = very low certainty). A meta-regression identified that statistical outliers and single-blinded studies contributed to the pooled g and heterogeneity. Omitting these studies resulted in a small effect (g = 0.110; 95% CI: 0.034 to 0.186), with negligible heterogeneity (I2 = 15.39; GRADE = high certainty). The effect size did not differ between classifications of cognitive impairment (ie, intact cognition, mild cognitive impairment, and dementia) in subgroup analysis (P = .729). CONCLUSION: The pooled findings indicated there is high-certainty evidence that vitamin B6, B9, or B12 supplementation has a very small benefit on global cognitive function in older adults. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42024553717. © The Author(s) 2025. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. DOI: 10.1093/nutrit/nuaf155 PMID: 40966571 [Indexed for MEDLINE]
8. Epilepsy Behav. 2025 Nov;172:110691. doi: 10.1016/j.yebeh.2025.110691. Epub 2025 Sep 5. Pyridoxine supplementation for levetiracetam-related neuropsychiatric adverse events in pediatric and adolescent epilepsy: a prospective, double-blind, randomized, placebo-controlled trial. Thananowan P(1), Simasathien T(2), Kitvorametha N(2), Kangwantanawat B(2), Suwanpakdee P(3). Author information: (1)Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. (2)Neurology Division, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. (3)Neurology Division, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. Electronic address: piradee@pedpmk.org. BACKGROUND: Levetiracetam commonly causes neuropsychiatric adverse events (NPAEs) in pediatric patients, including irritability and aggression. This study evaluated pyridoxine supplementation for reducing levetiracetam-related NPAEs in children and adolescents with epilepsy. METHODS: We conducted a prospective, double-blind, randomized, placebo-controlled trial at Phramongkutklao Hospital, Thailand (January-June 2024). Participants aged 1-18 years with levetiracetam-related NPAEs were randomly assigned in a 1:1 ratio to receive either pyridoxine (10 mg/kg/day, maximum 200 mg) or placebo for 8 weeks. The primary outcome was change in behavioral symptoms using a validated 30-item questionnaire (score range 30-90). Secondary outcomes included treatment adherence, time to behavioral improvement, and adverse events. Sample size (n = 102) was calculated to detect a 20 % difference in behavioral improvement with 80 % power. RESULTS: 102 patients were randomized (pyridoxine n = 51, placebo n = 51). Baseline characteristics-including age, sex, seizure type, and number of concomitant ASMs-were comparable between groups. The mean age was 9.2 vs 8.3 years (p = 0.363), and 52.9 % vs 51.0 % were female in the pyridoxine and placebo groups, respectively. Most participants (56.9 %) were on dual therapy, with a median of two ASMs in both groups (p = 0.94). Both groups showed significant behavioral improvement over 8 weeks: the pyridoxine group from 14.79 ± 6.87 to 11.54 ± 6.22 (p < 0.001); placebo group from 15.65 ± 8.26 to 10.47 ± 8.22 (p < 0.001). No significant between-group difference existed at week 8 (p = 0.468). However, multivariate analysis of behavioral change scores from baseline to week 8 revealed significantly greater improvement in the pyridoxine group (adjusted OR = 2.31, 95 % CI: 1.15-4.63, p = 0.020). No serious adverse events occurred in either group. CONCLUSION: While pyridoxine did not significantly reduce behavioral scores compared to placebo at the study endpoint, the greater improvement in change scores over time suggests potential benefit in mitigating levetiracetam-associated NPAEs. Pyridoxine may serve as safe adjunctive therapy for patients who have behavioral side effects while maintaining seizure control. Further investigation in larger multicenter trials with extended follow-up is required before recommending pyridoxine for routine clinical use. Copyright © 2025 Elsevier Inc. All rights reserved. DOI: 10.1016/j.yebeh.2025.110691 PMID: 40913882 [Indexed for MEDLINE] Conflict of interest statement: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
9. Adv Nutr. 2025 Jun;16(6):100440. doi: 10.1016/j.advnut.2025.100440. Epub 2025 May 10. Associations between Diet and Cognitive Function in Stroke Survivors: A Systematic Review and Meta-analysis. Amanat S(1), Dordevic AL(2), Brodtmann A(3), Cardoso BR(4). Author information: (1)Department of Nutrition, Dietetics and Food, Monash University, Victoria, Australia. (2)Department of Nutrition, Dietetics and Food, Monash University, Victoria, Australia; Victorian Heart Institute, Monash University, Victoria, Australia. (3)Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, Victoria, Australia; Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia; The Florey Institute for Neuroscience and Mental Health, Melbourne, Victoria, Australia. (4)Department of Nutrition, Dietetics and Food, Monash University, Victoria, Australia; Victorian Heart Institute, Monash University, Victoria, Australia. Electronic address: barbara.cardoso@monash.edu. Poststroke cognitive decline is a major form of disability in stroke survivors. Although dietary interventions have shown potential in improving cognitive outcomes in stroke-free populations, their effects on stroke survivors remain unclear. This review aimed to evaluate associations between diet and cognitive function in stroke survivors. MEDLINE, Embase, Scopus, and CINHAL were searched for studies from inception to 16 December, 2024. Eligible articles were observational and interventional studies on adult stroke survivors that evaluated the association/effect of any nutritional exposure/intervention on cognitive performance and dementia risk. Studies were excluded when an intervention was combined with nonnutritional treatment. Random-effects meta-analysis was used for similar randomized clinical trials. This review included 20 clinical trials and 14 observational studies assessing the intake of energy and proteins and a variety of single nutrients, as well as dietary patterns, single foods, and phytochemicals. Meta-analyses revealed a positive effect of energy-protein supplementation on global cognition [standardized mean difference (SMD): 0.62; 95% confidence interval (CI): 0.15, 1.08; P = 0.009], and a negative effect of B-vitamins (folic acid, vitamin B6, and vitamin B12) (SMD: -0.40; 95% CI: -0.72, -0.08; P = 0.02). Adherence to the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay and plant-based diets, as well as higher consumption of fruits, milk, coffee, vitamin E, and selenium, were related to better cognitive outcomes; no significant association was observed for adherence to DASH and Mediterranean diets and consumption of vitamins D and C. Butter and sugar intake and calcium supplementation were associated with negative cognitive outcomes. Mixed results were seen for omega (ω)-3, tea, and plant extracts. The available evidence indicates that energy-protein supplementation may benefit cognition after stroke, whereas B-vitamin supplementation has no effect. The substantial heterogeneity among studies hinders conclusions about other dietary strategies. This review was registered with PROSPERO as CRD42024541785. Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.advnut.2025.100440 PMCID: PMC12164037 PMID: 40355028 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest The authors report no conflicts of interest.
10. Depress Anxiety. 2024 Nov 11;2024:3661412. doi: 10.1155/2024/3661412. eCollection 2024. Effectiveness of a Saffron and Withania Supplement on Mood in Women With Mild-to-Moderate Anxiety During the COVID-19 Lockdown. Pages-García C(1), De Almagro MC(2), Ruiz-Moreno J(3), De Castellar R(4). Author information: (1)Obstetrics and Gynecology Department, Hospital Universitario, Toledo, Hospitales de Madrid HM IMI Toledo, Unidad de Suelo Pélvico, Toledo, Spain. (2)Parc Científic de Barcelona, Laboratorios Ordesa S.L., Barcelona 08028, Spain. (3)Head of Biometry, Mixestat S.L., Barcelona 08021, Spain. (4)Clinical Research Unit, Medical Affairs Department, Laboratorios Ordesa S.L, Barcelona 08038, Spain. Background: A nutritional supplement based on medicinal plants (saffron and ashwagandha), tryptophan, and vitamin B6 could contribute to alleviating/improving mood and associated disorders. The aim of this study was to evaluate the potential benefits of this combination supplement. During the study period, participants underwent a period of forced home confinement due to the COVID-19 pandemic, which represented an unexpected impact factor. Methods: This open-label prospective trial enrolled a cohort of female employees who reported mild to moderate anxiety. The primary objective was to evaluate changes in the level of anxiety using the adapted Hamilton Anxiety Rating Scale (HARS) after 12 weeks of regular supplementation with Safromotive (two tablets daily, for 12 weeks). The secondary objectives were to evaluate health-related quality of life (HRQoL) and tolerability. Results: In total, 46 women with a mean age of 45.0 (6.5) years were included. A statistically significant improvement in HARS was observed, with a 7.5-unit decrease from baseline to 12 weeks (p < 0.0001) and from 4 to 12 weeks of supplement intake (p=0.0058). However, no significant changes were found during the lockdown period (between weeks 8 and 12 of the study). No relationship was found between women's sociodemographic characteristics and the HARS total score. A significant reduction in the HRQoL questionnaire score of 1.2 units was observed between baselines and 12 weeks of treatment (p=0.0273). At the end of the study, 78.6% of the women reported consistency the supplement intake during the study course. Conclusion: This nutritional supplement composed of saffron, ashwagandha, tryptophan, and vitamin B6 appears to improve anxiety and HRQoL, but confinement could have impacted the evolution of the outcome. Copyright © 2024 Cristina Pages-García et al. DOI: 10.1155/2024/3661412 PMCID: PMC11919007 PMID: 40226680 [Indexed for MEDLINE] Conflict of interest statement: M. Cristina De Almagro and Roser De Castellar are employees of Laboratorios Ordesa S.L. The rest of the authors declare no conflicts of interest.
11. Nutrients. 2025 Mar 24;17(7):1122. doi: 10.3390/nu17071122. Effects of B Vitamins on Homocysteine Lowering and Thrombotic Risk Reduction-A Review of Randomized Controlled Trials Published Since January 1996. Li M(1), Ren R(2), Wang K(3), Wang S(4), Chow A(5), Yang AK(6), Lu Y(2)(7), Leo C(8). Author information: (1)Brigham and Women's Hospital, Boston, MA 02115, USA. (2)College of Pharmacy, University of Minnesota, Minneapolis, MN 55415, USA. (3)Fairbanks Memorial Hospital, 340 Cowles Street, Fairbanks, AK 99701, USA. (4)NYU Langone Hospital-Long Island, Mineola, NY 11501, USA. (5)College of Arts and Science, New York University, New York, NY 10012, USA. (6)Dartmouth College, Hanover, NH 03755, USA. (7)Department of Pharmacy, Hennepin Healthcare System, Minneapolis, MN 55415, USA. (8)Duke Raleigh Hospital, a Campus of Duke University Hospital, School of Medicine, Duke University, Durham, NC 27708, USA. Homocysteine is an amino acid derived from methionine which is metabolized via vitamin B6 (pyridoxine)- and vitamin B12 (cobalamin)-dependent pathways. Supplementation of B vitamins has been shown to effectively reduce plasma homocysteine levels. Previous research has also demonstrated an association between lower plasma homocysteine levels and decreased risk of myocardial infarction, stroke, and venous thromboembolism. However, whether supplementation of B vitamins is associated with risk reduction in thromboembolic events and confers clinical benefits remains inconclusive. This review examines clinical trials published over the past 29 years to assess the effects of B vitamin supplementation on thrombotic risk reduction and homocysteine metabolism. The findings from these studies are inconsistent, and the impact of B vitamins on thrombosis prevention remains uncertain. Given the conflicting evidence, further clinical and translational research is necessary to clarify the role of B vitamin supplementation in thrombosis risk reduction. DOI: 10.3390/nu17071122 PMCID: PMC11990291 PMID: 40218880 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflict of interest.
12. Brain Behav. 2025 Apr;15(4):e70432. doi: 10.1002/brb3.70432. Short-Term Effects of Folate Supplementation in Combination With Vitamin B6 for Treating Acute Manic Episodes in Bipolar I Disorder: A Randomized Controlled Trial. Akbarzadeh F(1), Talaei A(2), Nematy M(3), Ganji D(1), Ebrahimi A(1), Talaei A(1). Author information: (1)Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. (2)Faculty of Biotechnology, Tehran University, Tehran, Iran. (3)Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. BACKGROUND: Drug resistance poses a formidable challenge in managing acute manic episodes in bipolar I disorder, leading to suboptimal treatment outcomes. This study investigates the efficacy of folate and vitamin B6 supplementation as an adjunct to sodium valproate in improving treatment responses for patients experiencing acute mania. METHODS: In a randomized, double-blind, placebo-controlled trial, 43 patients diagnosed with bipolar I disorder presenting with acute manic episodes were enrolled. Participants were randomly assigned to three groups: one receiving folate (5 mg/day) plus vitamin B6 (80 mg/day), a second group receiving folate alone (5 mg/day), and a third group receiving placebo. Evaluations were conducted at baseline and after 3 and 6 weeks using the Mini-Mental State Examination (MMSE) and the Young Mania Rating Scale (YMRS). RESULTS: All groups demonstrated significant clinical improvements after the treatment period; however, the trends in MMSE scores showed no significant differences (p = 0.068). Notably, the reduction in YMRS scores significantly varied across groups (p < 0.001, effect size = 0.342), with the folate group demonstrating a significantly greater decrease compared to both the folate/B6 (p = 0.003) and placebo groups (p < 0.001). Recovery rates revealed that 80% of patients receiving folate showed over a 50% decrease in YMRS scores after 3 weeks, markedly higher than the other groups (p = 0.001). CONCLUSIONS: Our findings support the short-term use of folate as a beneficial adjunct in treating acute manic episodes in bipolar I disorder. However, the addition of vitamin B6 did not yield additional advantages. These results may inform future treatment guidelines targeting acute mania in bipolar disorder, advocating for folate supplementation as a potential strategy to enhance therapeutic outcomes. © 2025 The Author(s). Brain and Behavior published by Wiley Periodicals LLC. DOI: 10.1002/brb3.70432 PMCID: PMC11979356 PMID: 40200764 [Indexed for MEDLINE]
13. Heliyon. 2025 Feb 13;11(4):e42631. doi: 10.1016/j.heliyon.2025.e42631. eCollection 2025 Feb 28. A randomized multi-arm open labelled comparative clinical trial report of Pankajakasthuri DiabetEaze powder, a novel polyherbal formulation on the nutritional management and glycemic control in type 2 diabetic and prediabetic patients. Sasidharan S(1)(2), Nair A K(3), R L(3), Nair AV(4), Sa S(5), Joseph SG(6), Chand Cp A(3), Satheesan S(7), Pratap A(3), Kumar S N(2), Paul J(8), Nair V V(9), R V(6), Nair J H(4). Author information: (1)HCEMM-SU Cardiovascular Comorbidities Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University, 1089, Budapest, Hungary. (2)Department of R&D, Pankajakasthuri Herbal Research Foundation, Pankajakasthuri Ayurveda Medical College Campus, Trivandrum, India. (3)Department of Kayachikitsa, Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada, Thiruvananthapuram, Kerala, India. (4)Pankajakasthuri Herbals India Pvt. Ltd., Poovachal, Trivandrum, India. (5)Department of Rasashastra & Bhaishajya Kalpana, Pankajakasthuri Ayurveda Medical College & P.G. Centre, Killy, Kattakada, Thiruvananthapuram, Kerala, India. (6)Department of Dravyagunavijnanam, Pankajakasthuri Ayurveda Medical College & P.G. Centre, Killy, Kattakada, Thiruvananthapuram, Kerala, India. (7)Department of Shalyatantra, Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada, Thiruvananthapuram, Kerala, India. (8)Department of Statistics, Vimala College (Autonomous), Thrissur, Kerala, 680009, India. (9)Neyyar Medicity, Killy, Kattakada, Thiruvananthapuram, Kerala, India. BACKGROUND AND AIMS: Recently Diabetes Mellitus (DM) has been associated with heightened susceptibility to malnutrition, suggesting that augmenting nutritional intake stands out as a potent therapeutic strategy for addressing malnutrition in individuals with DM. The aim of this clinical investigation was to evaluate the effect of DiabetEaze powder, a polyherbal nutritional formulation developed by us for nutritional management and glycaemic control, on patients with diabetic and prediabetic conditions. METHODS: A total of 143 type II diabetic (T2D) patients who were managing their diabetic condition through modern medicine, AYUSH medicine, lifestyle modification and 68 pre-diabetic patients, aged between 40 and 65 years, were randomly assigned into six groups: control, modern, AYUSH, lifestyle, prediabetic control and prediabetic trial. The treatment groups were administered 5 g of DiabetEaze powder two times a day after food for 6 months. Microminerals, vitamins, glycaemic parameters, Quality of Life (QoL), hematology, lipid profiles, Renal Function Test (RFT) and Liver Function Test (LFL) parameters, and electrolytes were evaluated at Day 0, Day 90, and Day 180. RESULTS: Out of 211 enrolled patients, 189 individuals successfully completed the entire 180-day duration of the study, indicating a retention rate of approximately 89.6 %. In our study, we observed a statistically significant elevation in the levels of vitamin D, B2, and B6 across all treatment groups. Besides, the treatment groups displayed a notable increase in zinc and manganese levels compared to the other minerals tested. Notably, the treatment groups demonstrated distinct mineral and vitamin profiles. In terms of metabolic markers, significant reductions in Fasting Blood Sugar (FBS)/Post Prandial Blood Sugar (PPBS) were observed across the modern, AYUSH, and lifestyle groups, while the modern group also showed a marked decrease in glycated haemoglobin (HbA1c) levels. Furthermore, overall QoL among the tested groups was also statistically significant. The consistent maintenance of normal LFT and RFT parameters and electrolyte levels across trial groups throughout the study duration indicates that the supplement does not induce liver toxicity or negatively impact hepatic function. CONCLUSION: In conclusion, the nutrients present in the DiabetEaze powder contribute to the effective management of nutritional status in diabetic people and thus effectively reduce sugar spikes by regulating PPBS and HbA1c levels, which is a critical aspect of its role in diabetes management. These properties benefit in managing diabetes-related outcomes and overall quality of life. CLINICAL TRIAL REGISTRY OF INDIA UNDER REGISTRATION NO: CTRI/2021/04/032956 on 20/04/2021. © 2025 The Authors. DOI: 10.1016/j.heliyon.2025.e42631 PMCID: PMC11903805 PMID: 40083990 Conflict of interest statement: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Dr. Shan Sasidharan reports financial support was provided by Department of Pharmacology and Pharmacotherapy, Semmelweis University & Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada, Thiruvananthapuram, Kerala, India. Dr. Shan Sasidharan reports a relationship with Department of Pharmacology and Pharmacotherapy, Semmelweis University & Pankajakasthuri Ayurveda Medical College & PG Centre, Killy, Kattakada, Thiruvananthapuram, Kerala, India that includes: employment. Dr. Shan Sasidharan has patent nil pending to nil. nil If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
14. Eur J Nutr. 2025 Mar 12;64(3):124. doi: 10.1007/s00394-025-03643-8. Mulberry leaf extract combined with tryptophan improves sleep and post wake mood in adults with sleep complaints - A randomized cross-over study. Soon CS(#)(1), Thota R(#)(2), Owen L(2), Tian L(1), Martin FP(2), Mantantzis K(2), Cherta-Murillo A(2), Campos VC(2), Chkroun C(3), Lavalle L(3), Hartweg M(3), St-Onge MP(4), Chee MWL(1), Darimont C(5). Author information: (1)Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. (2)Nestlé Institute of Health Sciences, Nestlé Research, Lausanne, Switzerland. (3)Clinical Research Unit, Nestlé Research, Lausanne, Switzerland. (4)Division of General Medicine and Center of Excellence for Sleep & Circadian Research, Department of Medicine, Columbia University Irving Medical Center, New York, USA. (5)Nestlé Institute of Health Sciences, Nestlé Research, Lausanne, Switzerland. christian.darimont@rdls.nestle.com. (#)Contributed equally PURPOSE: In the current study we evaluated a blend of ingredients containing mulberry leaf extract (to lower postprandial glucose of the evening meal), tryptophan (facilitator of the sleep initiation) to benefit sleep initiation and quality in adults with self-reported difficulties with sleep initiation. METHODS: Forty-three adults aged between 25 and 50 years enrolled in a randomized, crossover, double-blind, controlled trial. Participants received standardized meals with a glycemic load of 55 ± 10% and were assigned to receive treatment comprising a combination of mulberry leaf extract (750 mg), whey protein containing 120 mg tryptophan, zinc (1.35 mg), magnesium (12.6 mg), vitamin B3 (1.93 mg) and B6 (0.135 mg) and control (4 g wheat protein hydrolysate). Each intervention phase lasted 14 days separated by a washout period of 28 days. The primary outcomes were actigraphy-measured sleep onset latency and sleep efficiency. Secondary outcomes included continuous glycemic responses, mood, and cognition. RESULTS: A linear mixed model intention-to-treat analysis conducted on 42 participants found that the treatment reduced sleep onset latency (actigraphy: -3.82 mins, p = 0.026; self-report: -3.09 mins, p = 0.048). Treatment significantly reduced evening meal's postprandial glucose response (incremental area under the curve, mmol/L*min) at 1 hour by 21% (p < 0.001), incremental maximum concentration by 16% (p = < 0.001) and nocturnal glucose variation over the 14-day period. Participants on treatment reported improved sleep quality (Karolinska Sleepiness Scale, -0.17, p = 0.041) and feeling more relaxed (Brief Mood Introspection Scale, -0.4, p = 0.003) the next morning compared to when taking the control. Additionally, the treatment improved the vigor dimension on the Profile of Mood Scale (0.8, p = 0.038). No effects were observed on the cognitive performance. Lowering postprandial glucose significantly mediated the treatment effect of lowering sleep onset latency and lower nocturnal glucose variation was also associated with improved sleep quality and next-day positive mood. CONCLUSION: The evening meal supplement benefited sleep initiation and quality, and also improved post wake mood in adults. TRIAL REGISTRATION: Registration number of Clinical Trial - ClinicalTrials.gov NCT05372900. © 2025. Springer-Verlag GmbH Germany, part of Springer Nature. DOI: 10.1007/s00394-025-03643-8 PMCID: PMC12074979 PMID: 40072601 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Conflict of interest: ACM, VCC, PL, JJS, CC, LL, MH, MBL, EDL, JH, CD are employed by Société des Produits Nestlé SA. RT, LO, FPM, KM, GMTL, FMS were employed by Société des Produits Nestlé SA during the period of this work. MWLC received an honorarium for the time contributed to manuscript development. MPS is supported by R01HL142648; R01DK128154; R35HL155670.
15. Nutr Rev. 2025 Jul 1;83(7):e1533-e1543. doi: 10.1093/nutrit/nuae191. Effect of Nutritional Supplements for Reducing Homocysteine Levels in Healthy Adults: A Systematic Review and Network Meta-Analysis of Randomized Trials. Liu C(1), Yao H(1), Wang F(1). Author information: (1)Department of Reproductive Medicine, The Second Hospital of Lanzhou University, Lanzhou City, Gansu Province, China. CONTEXT: There are various therapeutic approaches available to reduce homocysteine (Hcy) levels. However, it remains unclear which intervention is more effective for healthy adults. OBJECTIVES: A systematic review and network meta-analysis (NMA) were conducted to comprehensively investigate the efficacy of different nutritional supplements in reducing Hcy levels in healthy adults. DATA SOURCES: The PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to July 2023. DATA EXTRACTION: The lead author, year of publication, sample size, population characteristics, intervention measures, duration, and mean difference of Hcy levels from baseline to endline were extracted. DATA ANALYSIS: Data were pooled using a random-effects model. Network meta-analysis was conducted by integrating direct and indirect evidence. A total of 16 studies were included in this analysis. The nutritional supplement combination that achieved the highest ranking (surface under the cumulative ranking curve [SUCRA] = 75.8) was superior compared with a single supplement. Among similar or closely dosed folic acid (FA) supplements, 800 μg FA (SUCRA = 93.7) was the most effective option. When comparing various doses of different supplements, 1 mg of FA plus 7.2 mg of vitamin B6 (B6) plus 20 μg of vitamin B12 (B12; SUCRA = 83.9) ranked first and 800 μg of FA (SUCRA = 78.3) ranked second. In comparison with placebo or no-treatment control groups, interventions such as 1 mg of FA plus 7.2 mg of B6 plus 20 μg of B12 (mean difference [MD] = -1.03; 95% CI -1.71 to -0.36), 400 μg of FA plus 400 μg of B12 (MD = -0.87; 95% CI -1.46 to -0.27), and 800 μg of FA (MD = -0.84; 95% CI -1.12 to -0.56) were more effective in reducing Hcy levels. The random-effects summary MD for all interventions compared with placebo was -0.59 (95% CI -0.71 to -0.48; P < .0001). CONCLUSIONS: The NMA demonstrated that the combination of FA with other vitamins is more effective in reducing Hcy levels, particularly when the dose of FA is close to 800 μg. The combination of 1 mg of FA, 7.2 mg of B6, and 20 μg of B12 is considered the most favorable option. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42023453123. © The Author(s) 2025. Published by Oxford University Press on behalf of the International Life Sciences Institute. DOI: 10.1093/nutrit/nuae191 PMCID: PMC12166197 PMID: 39960689 [Indexed for MEDLINE] Conflict of interest statement: The authors declare there is no conflict of any relevant interests.
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