갈락토올리고당 (GOS)

Infant formulae supplemented with prebiotics: Are they better than unsupplemented formulae? An updated systematic review.

1. Br J Nutr. 2018 Apr;119(7):810-825. doi: 10.1017/S0007114518000120. Epub 2018 Feb 19. Infant formulae supplemented with prebiotics: Are they better than unsupplemented formulae? An updated systematic review. Skórka A(1), Pieścik-Lech M(1), Kołodziej M(1), Szajewska H(1). Author information:

Two-week supplementation of Bifidobacterium adolescentis iVS-1 reduces symptoms associated with lactose intolerance in lactose maldigesters.

1. Gut Microbes Rep. 2025 Jun 4;2(1):2508199. doi: 10.1080/29933935.2025.2508199. eCollection 2025. Two-week supplementation of Bifidobacterium adolescentis iVS-1 reduces symptoms associated with lactose intolerance in lactose maldigesters. Ramakrishnan M(1), Cross TL(1), Organski AC(1), Saiprasad SM(1), Simpson AMR(1)(2), Tancredi DJ(3), Van Haute MJ(4), Christensen CM(4), Lewis ZT(5), Auchtung TA(4), Walter J(6), Hutkins R(7), Savaiano DA(1). Author information: (1)Department of Nutrition Science, Purdue University, West Lafayette, IN, USA. (2)Department of Ecology & Evolutionary Biology, University of California, Irvine, CA, USA. (3)Department of Pediatrics, UC Davis, Sacramento, CA, USA. (4)Synbiotic Health, Lincoln, NE, USA. (5)Lewpine Consulting LLC, American Fork, UT, USA. (6)School of Microbiology, Department of Medicine, and APC Microbiome Ireland, University College Cork, Cork, Ireland. (7)Department of Food Science and Technology, Nebraska Food for Health Center, University of Nebraska, Lincoln, NE, USA. Probiotic supplements containing high β-galactosidase-producing bacteria may aid in the management of lactose intolerance. We previously isolated a strain of Bifidobacterium adolescentis, iVS-1, from the fecal sample of a human donor after consumption of galactooligosaccharides (GOS), a prebiotic derived from lactose. Therefore, it was hypothesized that iVS-1 might reduce symptoms associated with lactose maldigestion. Compared to other probiotic strains, iVS-1 had high β-galactosidase activity and reduced gas formation by fecal communities during in vitro fermentations of lactose or milk. A randomized placebo-controlled clinical trial was then conducted with 21 lactose maldigesters, randomized to receive either B. adolescentis iVS-1 (n = 11) or placebo (n = 10) daily for 2 weeks. Compared to the two-week run-in period, iVS-1 abundance was higher both at the end of the treatment period (p = 0.0005) and after the 2-week post-treatment period (p = 0.045). The iVS-1 group reported less overall daily symptoms during the treatment period when compared to placebo (p = 0.032) and had significant improvement for fecal urgency (p = 0.033) and diarrhea (p = 0.006). The metabolism of lactose, reduction of gas, and improvement of multiple gastrointestinal symptoms suggest that B. adolescentis iVS-1 may be an effective treatment for lactose intolerance. Trial Registration: The trial is registered at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT05668468). © 2025 The Author(s). Published with license by Taylor & Francis Group, LLC. DOI: 10.1080/29933935.2025.2508199 PMCID: PMC12940102 PMID: 41909904 Conflict of interest statement: MJVH, CMC, ZTL, and TAA are affiliated with, and JW and RH are advisors to, Synbiotic Health, which provided funding for this study. The other authors declare no conflicting interest.

Prebiotics and Gut Health: Mechanisms, Clinical Evidence, and Future Directions.

2. Nutrients. 2026 Jan 23;18(3):372. doi: 10.3390/nu18030372. Prebiotics and Gut Health: Mechanisms, Clinical Evidence, and Future Directions. Monteiro CRAV(1)(2), Bogea EG(1)(2), Campos CDL(1), Pereira-Filho JL(1), Almeida VSS(1), Vale AAM(1), Azevedo-Santos APS(1), Monteiro-Neto V(1). Author information: (1)Center of Biological and Health Sciences, Federal University of Maranhão, Bacanga Campus, São Luís 65080-805, MA, Brazil. (2)School of Physical Therapy, Florence University Center, São Luís 65.020-490, MA, Brazil. BACKGROUND/OBJECTIVES: Prebiotics, which are non-digestible compounds that selectively modulate gut microbiota, are recognized for their potential to promote host health. Although their bifidogenic effect is well documented, a systematic synthesis of how this microbial modulation translates into clinical gastrointestinal (GI) and metabolic outcomes across diverse populations is needed. This review aims to integrate mechanistic insights with clinical evidence to elucidate the pathway from prebiotic structures to tangible health benefits. METHODS: This comprehensive narrative review details the structural properties of major prebiotics (e.g., inulin, FOS, and GOS) that govern their fermentation and the production of short-chain fatty acids (SCFAs). To evaluate clinical efficacy, an analysis of 22 randomized controlled trials from the past decade was conducted, focusing on human studies that utilized ISAPP-recognized prebiotics as the sole intervention. RESULTS: The analysis confirms that prebiotic supplementation consistently increased the abundance of beneficial bacteria (e.g., Bifidobacterium and Lactobacillus) and SCFA production. These changes are associated with significant clinical improvements, including enhanced stool frequency and consistency, strengthened intestinal barrier function, and modulated immune responses. Benefits have been documented in healthy individuals, children, the elderly, and those with conditions such as constipation, metabolic syndrome, and antibiotic-associated dysbiosis. However, significant inter-individual variability in response was evident, and the study designs showed notable heterogeneity in prebiotic type, dosage, and duration. CONCLUSIONS: Prebiotics are effective modulators of gut health, driving clinical benefits through selective microbial fermentation and SCFA production. The documented heterogeneity and variability highlight the need for future research to focus on personalized nutritional strategies. Key priorities include standardizing intervention protocols, elucidating dose-response relationships, integrating multi-omics data to link taxonomy to function, and exploring novel applications such as synbiotic formulations and gut-brain axis modulation. DOI: 10.3390/nu18030372 PMCID: PMC12899272 PMID: 41683196 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.

Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT.

3. BMC Pediatr. 2026 Jan 13;26(1):250. doi: 10.1186/s12887-025-06454-2. Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT. Fabrizio V(1)(2), Abdelmagid SA(3), Bose A(4), Hale M(5), Hays EC(6), Hudson M(7), Hughes T(8), Leonard D(9), Rouse K(10), Sideri M(11), Walker J(12), Wampler JL(12), Yeiser M(13), Zhuang W(12), Wu SS(12)(14). Author information: (1)Evidence Generation and Clinical Research, Mead Johnson Nutrition, Evansville, IN, USA. veronica.fabrizio@reckitt.com. (2)Indiana University School of Medicine, Evansville, IN, USA. veronica.fabrizio@reckitt.com. (3)Regulatory Affairs, Mead Johnson Nutrition, Toronto, ON, Canada. (4)PAS Research, McAllen, TX, USA. (5)Birmingham Pediatric Associates, Birmingham, AL, USA. (6)The Jackson Clinic - North Jackson, Jackson, TN, USA. (7)DCOL Center for Clinical Research, Longview, TX, USA. (8)PAS Research, Tampa, FL, USA. (9)Meridian Clinical Research, Hastings, NE, USA. (10)The Children's Clinic of Jonesboro, PA, Jonesboro, AR, USA. (11)Nutrition Science, Mead Johnson Nutrition, Amsterdam, The Netherlands. (12)Evidence Generation and Clinical Research, Mead Johnson Nutrition, Evansville, IN, USA. (13)Spring Medical Research, Owensboro, KY, USA. (14)Indiana University School of Medicine, Evansville, IN, USA. BACKGROUND: Partially hydrolyzed cow's milk protein (PHP) formulas are nutritionally complete and have a high-quality protein composition, and extensive history of safe use. The current study evaluated growth and safety in healthy term infants receiving a new PHP formula with an added prebiotic blend. METHODS: In this multi-center, double-blind, controlled, parallel, prospective study, healthy term infants were randomized to receive one of two formulas through 365 days of age: previously marketed intact cow's milk protein formula (Control, n = 122) or investigational PHP formula (INV-PHP, n = 122). Both formulas had an added prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) (1:1, 4 g/L). The primary outcome was rate of weight gain (g/day) from 14 to 120 days of age. To establish equivalence between study formulas, the 90% two-sided confidence interval (CI) of the mean group difference in body weight growth rate from 14 to 120 days of age needed to be contained within a predefined equivalence interval (± 3 g/day). Growth rates through Day 120 and achieved anthropometrics through Day 365 were analyzed by ANOVA. Parent-reported tolerance outcomes were also collected. Medically confirmed adverse events were collected throughout the study period. RESULTS: Of 244 infants enrolled and randomized (Control, n = 122; INV-PHP, n = 122); 175 completed study feeding through Day 120 (Control, n = 91; INV-PHP, n = 84). Equivalence in rate of weight gain from 14 to 120 days of age was demonstrated with the difference in means of 0.5 g/day and 90% CI [- 1.10, 2.08 g/day] within the predefined equivalence interval (± 3 g/day). Mean achieved weight remained between 25th -75th reference percentiles of the WHO growth standard through Day 180 by sex and subsequently tracked between 50th -90th percentiles through Day 365. Formula acceptance and tolerance were good. Stool consistency remained soft in both groups throughout the study. No significant group differences in mean fussiness and gassiness scores, or medically confirmed adverse events were detected. A total of 159 participants completed the Day 365 visit (Control, n = 82; INV-PHP, n = 77). CONCLUSIONS: Overall, partially hydrolyzed cow's milk protein infant formula with an added prebiotic was safe, well-tolerated, and associated with adequate growth for healthy term infants receiving formula through one year of age. TRIAL REGISTRATION: ClinicalTrials.gov, ClinicalTrials.gov Identifier NCT05047978. Registered 28 August 2021, https://clinicaltrials.gov/study/NCT05047978. © 2026. The Author(s). DOI: 10.1186/s12887-025-06454-2 PMCID: PMC13040795 PMID: 41527066 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: Parents or legally authorized representatives provided written informed consent prior to enrollment. The research protocol and informed consent forms observing the Declaration of Helsinki (including October 1996 amendment) were submitted and approved by Advarra Institutional Review Board (Advarra, Inc. Columbia, MD) an independent, public IRB. Each participating site was granted individual site-specific approval by Advarra Institutional Review Board. (Advarra, Inc. Columbia, MD). The study complied with good clinical practices. Consent for publication: Not applicable. Competing interests: A.B., M.H., D.L., T.H., M.H., E.C.H., K.R., and M.Y. have received support for study site coordination and data collection from Mead Johnson Nutrition. V.F., J.W., and W.Z. work in the Department of Medical Affairs; S.A.A. works in Regulatory Affairs, and M.S. works in Nutrition Science at Mead Johnson Nutrition. S.S.W. and J.L.W. were previously employed by Mead Johnson Nutrition.

A young child formula with Limosilactobacillus reuteri and GOS modulates gut microbiome and enhances bone and muscle development: a randomized trial.

4. Nat Commun. 2025 Dec 12;17(1):237. doi: 10.1038/s41467-025-66930-2. A young child formula with Limosilactobacillus reuteri and GOS modulates gut microbiome and enhances bone and muscle development: a randomized trial. Bonnet N(1), Capeding MR(2), Siegwald L(1), Garcia-Garcera M(1), Desgeorges T(1), Tytgat HLP(1), Krattinger LF(3), Lebumfacil J(4), Phee LC(2), Moll JM(5), Gudjonsson A(5), Rodriguez-Garcia P(5), Baruchet M(1), Feige JN(1), Jankovic I(6), Chen Y(6), Egli D(6), Horcajada MN(7). Author information: (1)Nestlé Institute of Health Sciences, Nestlé Research, Vers-Chez-Les-Blanc & EPFL innovation Park, Lausanne, Switzerland. (2)Clinical Research Unit, Asian Foundation for Tropical Medicine Inc. (AFTMI), Muntinlupa City, Philippines. (3)Clinical Research Unit, Nestlé Research, Lausanne, Switzerland. (4)Wyeth Nutrition, Makati City, Philippines. (5)Cmbio, Copenhagen, Denmark. (6)Nestlé Product Technology Center-Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland. (7)Nestlé Institute of Health Sciences, Nestlé Research, Vers-Chez-Les-Blanc & EPFL innovation Park, Lausanne, Switzerland. marienoelle.horcajada@rdls.nestle.com. In this randomized, double-blind controlled trial, 182 Filipino children aged 2-3 years received either an experimental young child formula (EYCF) containing a combination of Limosilactobacillus reuteri DSM 17938 and galacto-oligosaccharides (GOS; n = 91) or a minimally fortified milk (CM; n = 91) for 6 months. Primary outcome was tibia speed of sound and secondary outcomes were muscle strength, blood vitamin D levels, bone turnover markers, gut microbiota, fecal calcium fatty acid soaps and gastro-intestinal tolerance. Compared to CM, those in the EYCF group showed increased tibia speed of sound after 3 and 6 months. The intervention remodeled the stool microbiome composition, assessed by shotgun metagenomics, with enrichment of L. reuteri and higher bifidobacteria presence in the EYCF group. Increased L. reuteri abundance after 6 months of EYCF consumption associates with higher bone quality and muscle strength. Stool metabolomics show 45 metabolites modulated by EYCF consumption and associated to microbiome compositional changes, leading to enrichment of tryptophane and indole metabolism. In summary, consumption of EYCF containing a L. reuteri + GOS synbiotic improves musculoskeletal development in toddlers via modulation of microbiota composition and function. These results provide insights on gut-musculoskeletal crosstalk during early life. Clinicaltrial.gov NCT04799028. © 2025. The Author(s). DOI: 10.1038/s41467-025-66930-2 PMCID: PMC12783733 PMID: 41387706 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: Some authors (N.B., L.S., M.G.G., T.D., H.L.P.T., L.F.K., J.L., M.B., J.N.F., I.J., Y.C., D.E., and M.N.H.) are employees from Société des Produits Nestlé SA. Cmbio employees (J.M.M., A.G., and P.R.G.) contributed within a service agreement contract. M.R.C. and L.C.P. had no conflict of interest to report.

Evaluation of antenatal prebiotic intake in infants at risk of atopy: the double-blind PREGRALL randomized clinical trial.

5. Br J Dermatol. 2026 Feb 18;194(3):441-449. doi: 10.1093/bjd/ljaf414. Evaluation of antenatal prebiotic intake in infants at risk of atopy: the double-blind PREGRALL randomized clinical trial. Barbarot S(1)(2), Aubert H(2), Boivin M(3), Foureau A(2), Maruani A(4), Droitcourt C(5), Mazereeuw-Hautier J(6), Faurel-Paul E(7), Le Thuaut A(8), Tching-Sin M(9), Dochez V(10), Brosseau C(11), Bodinier M(11). Author information: (1)INRAE Pays de la Loire, Phan, Nantes, France. (2)CHU Nantes, Nantes Université, INSERM, Service de Dermatologie, CIC 1413, Nantes, France. (3)Centre Hospitalier Universitaire De Nantes, CIC Femmes Enfants Adolescents, Nantes, France. (4)Université de Tours, CHRU de Tours, Inserm1246-SPHERE, Service de Dermatologie et CIC Inserm 1415, Tours, France. (5)Centre Hospitalier Universitaire de Rennes, Chu Pontchaillou, Service De Dermatologie, Rennes, France. (6)Centre Hospitalier Universitaire de Toulouse, Hôpital Larrey, Service De Dermatologie, Toulouse, France. (7)Centre Hospitalier Universitaire De Nantes, Direction Recherche et Innovation, Nantes, France. (8)Centre Hospitalier Universitaire De Nantes, Direction Recherche et Innovation, Plateforme De Méthodologie et Biostatistique, Nantes, France. (9)Centre Hospitalier Universitaire De Nantes, Service De Pharmacie, Nantes, France. (10)Centre Hospitalier Universitaire De Nantes, Service de Gynécologie Obstétrique, CIC Femmes Enfants Adolescents, Nantes, France. (11)INRAE Pays De La Loire, UR 1268 BIA, Nantes, France. BACKGROUND: New primary preventive therapeutic strategies for atopic dermatitis (AD) are needed. Atopic diseases are associated with disrupted gut microbial balance in early life, suggesting that optimizing microflora through intervention could improve health. Prebiotics, which are immunomodulatory sugars, promote gut microbiota diversity. Most clinical trials focus on improving postnatal infant gut colonization, but prenatal life is crucial for establishing tolerance mechanisms. Preclinical studies indicate that maternal intake of galacto-oligosaccharide (GOS)/inulin prebiotics decreases the risk of food allergy in offspring. OBJECTIVES: To determine whether antenatal prebiotic intake prevents AD in children at high risk of atopy. METHODS: The multicentre double-blind randomized PREGRALL clinical trial ran from February 2018 to April 2023 (ClinicalTrials.gov NCT03183440). The follow-up period extended from 20 weeks of amenorrhoea in pregnant women to their infants reaching 1 year of age. Women with a physician-diagnosed history of atopy (asthma, allergic rhinitis, AD or food allergy) were selected for inclusion. The women were randomized to daily prebiotic GOS/inulin (n = 188) or placebo (maltodextrin; n = 188 participants) intake from 20 weeks' gestation until delivery. The first outcome was the occurrence of AD at 1 year in children at risk of the disease. Secondary endpoints included AD severity, quality of life, prebiotic tolerance and the prevalence of other atopic diseases. RESULTS: Of 376 pregnant women included in the trial, prebiotic supplementation did not prevent AD at 1 year (intention-to-treat population odds ratio 1.01, 95% confidence interval 0.59-1.74; P = 0.97) or reduce disease severity in their children. Subgroup analyses by breastfeeding status or delivery mode revealed no differences. No effects on allergen sensitization or food allergies were found. CONCLUSIONS: We found no evidence that maternal intervention with prebiotics protects against AD at 1 year of age in infants at risk of allergic diseases. Plain Language Summary: Atopic dermatitis is a skin condition that causes skin to become red, itchy and inflamed. It is also known as eczema. The condition affects 1 in 5 children worldwide. In France, a team of specialists at a number of university hospitals ran a clinical trial called ‘PREGRALL’. The trial was designed to find out whether giving pregnant women daily prebiotics could lower the chances of eczema in their babies. Between February 2018 and April 2023, 376 pregnant women who had asthma, hay fever, eczema or food allergies were split into two groups. From 20 weeks of pregnancy until they gave birth, women in one group took the prebiotic mix each day. A prebiotic is a type of dietary fibre that feeds good bacteria in the gut. Women in the other group took a harmless dummy drug (‘placebo’) that looked the same as the prebiotic. Neither the doctors nor the mothers knew who was taking the prebiotic or the placebo. When the babies were 1 year old, doctors checked how many had eczema, how severe it was and whether they had any other allergies. We found there was no difference. Babies whose mothers had taken prebiotics when they were pregnant developed eczema just as often and just as severely as those whose mothers had taken the placebo. There were also no changes in food allergies or skin test reactions. Our findings suggest that taking prebiotics during pregnancy alone does not prevent eczema in babies at high risk of the condition. Future studies will need to explore a combination of strategies to find effective ways to prevent eczema before it starts. © The Author(s) 2025. Published by Oxford University Press on behalf of British Association of Dermatologists. 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/bjd/ljaf414 PMID: 41250898 [Indexed for MEDLINE]

Effects of Mulberry Leaf and Corn Silk Extracts Against α-Amylase and α-Glucosidase In Vitro and on Postprandial Glucose in Prediabetic Individuals: A Randomized Crossover Trial.

6. Nutrients. 2025 Oct 31;17(21):3438. doi: 10.3390/nu17213438. Effects of Mulberry Leaf and Corn Silk Extracts Against α-Amylase and α-Glucosidase In Vitro and on Postprandial Glucose in Prediabetic Individuals: A Randomized Crossover Trial. Sun Y(1), Niu X(2), Wang Y(2), Zhang Q(2), Liu Y(3), He J(2), Xu L(4), Wang R(2), Guo J(2). Author information: (1)College of Food Science and Engineering, Tianjin University of Science and Technology, Tianjin 300457, China. (2)Key Laboratory of Precision Nutrition and Food Quality, Department of Nutrition and Health, China Agricultural University, Beijing 100080, China. (3)National Center of Technology Innovation for Dairy, Hohhot 010110, China. (4)Key Laboratory of Endocrinology of National Health Commission, Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing 100730, China. OBJECTIVE: Postprandial hyperglycemia is a major risk factor for type 2 diabetes and cardiovascular disease. Inhibition of α-amylase and α-glucosidase can attenuate postprandial glycemic response (PPGR). This study aimed to investigate the inhibitory effects of mulberry leaf and corn silk on these enzymes in vitro and their impact on postprandial glucose (PG) levels in prediabetic individuals using milk-based matrices. RESEARCH DESIGN AND METHODS: In vitro, enzyme inhibition was assessed using the DNS method (α-amylase) and pNPG method (α-glucosidase). A randomized crossover trial was conducted in 11 prediabetic individuals with four interventions: pure milk; lactose-hydrolyzed milk; lactose-hydrolyzed milk with mulberry leaf, corn silk, and resistant dextrin; and GOS milk with mulberry leaf and corn silk. PPGR was assessed by area under the glucose curve, 1 and 2 h PG, maximum PG, and 2 h glucose excursion. Paired Wilcoxon signed-rank tests were used for comparisons. RESULTS: Mulberry leaf and corn silk extracts inhibited both enzymes dose-dependently, with synergistic effects. No significant differences in PPGR indices were observed across interventions in the overall prediabetic individuals. However, in the overweight subgroup, the combination of GOS milk supplemented with mulberry leaf and corn silk significantly reduced 1 h PG (median difference [P25, P75]: -0.84 mmol/L [-1.05, -0.49]), maximum PG (-0.54 mmol/L [-0.75, -0.25]), and glucose excursion (-0.62 mmol/L [-0.75, -0.24]) compared to pure milk. CONCLUSIONS: Mulberry leaf and corn silk extracts inhibit α-amylase and α-glucosidase in vitro and may attenuate postprandial glucose excursions in overweight prediabetic individuals when delivered in a GOS milk matrix. DOI: 10.3390/nu17213438 PMCID: PMC12610157 PMID: 41228506 [Indexed for MEDLINE] Conflict of interest statement: The authors have no conflicts of interest to disclose.

The Effects of 12-Week Prebiotic Supplementation on General Wellness and Exercise-Induced Gastrointestinal Symptoms in Recreationally Trained Endurance Athletes: A Triple-Blind Randomised Controlled Pilot Trial.

7. Nutrients. 2025 Oct 28;17(21):3390. doi: 10.3390/nu17213390. The Effects of 12-Week Prebiotic Supplementation on General Wellness and Exercise-Induced Gastrointestinal Symptoms in Recreationally Trained Endurance Athletes: A Triple-Blind Randomised Controlled Pilot Trial. Gough LA(1), Weldon A(1), Clark CCT(1), Young A(1), Roberts CJ(1), Clarke ND(1), Brown MA(2), Williams R(1). Author information: (1)Research for Human Performance and Health Laboratory, Birmingham City University, Birmingham B42 2LR, UK. (2)Carnegie School of Sport, Leeds Beckett University, Leeds LS1 3HE, UK. Background/Objectives: Ingestion of galactooligosaccharides (GOSs) or GOS mixtures has been purported to improve exercise-induced gastrointestinal (GI) distress and post-exercise recovery. However, the effects have not been explored in recreationally trained endurance athletes. This triple-blind randomised controlled trial, therefore, investigated whether 12 weeks of B-GOS® supplementation affects gastrointestinal comfort and psychological wellbeing in recreational athletes. Methods: Eighteen physically active individuals (12 males, 8 females, 44 ± 14 years, 1.7 ± 0.1 m and 73 ± 14 kg) volunteered for this study. Participants were assigned to independent groups in a placebo-controlled, triple-blind manner via stratified randomisation. A 20 min run at 80% VO2max was completed, with measures for GI distress and Competitive State Anxiety Inventory-2 questionnaire (CSAI-2) pre- and post-exercise. A 12-week supplementation period then ensued, where participants ingested either 3.65 g of B-GOS or an appearance-matched maltodextrin placebo. During this time, physical activity levels (IPAQ-7), general stress (REST-Q), mental wellbeing (WEMWBS), and sleep (core consensus sleep diary) were measured at regular time points. Results: There were no significant differences in VO2max (p = 0.437), GI discomfort (p = 0.227), or CSAI-2 (p = 0.739-0.954) from pre- to post-exercise at any time point or between conditions. Over the 12 weeks there were no significant differences between B-GOS and placebo in IPAQ-7 (p = 0.144-0.723), REST-Q (p = 0.282-0.954), WEMWBS (B-GOS pre = 51 ± 10, post = 53 ± 7; PLA pre = 51 ± 4, post 54; p = 0.862), or sleep (p = 0.065-0.992). The linear mixed model suggests that some may benefit on an individual level in terms of WEMWBS, general stress score, recovery-related scores, sleep, and sport-specific recovery score. Conclusions: There were no group benefits of B-GOS supplementation compared with placebo, although the individual variation may warrant further research in larger sample sizes and longer-duration studies. DOI: 10.3390/nu17213390 PMCID: PMC12610699 PMID: 41228463 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest. The funders (Clasado Limited) had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Effect of Daily Lactococcus cremoris spp. Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers: A Randomized Placebo-Controlled Clinical Trial.

8. Medicina (Kaunas). 2025 May 22;61(6):956. doi: 10.3390/medicina61060956. Effect of Daily Lactococcus cremoris spp. Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers: A Randomized Placebo-Controlled Clinical Trial. Bousdouni P(1), Kandyliari A(1)(2), Kargadouri A(3), Potsaki P(1), Papagianni OI(1), Stylianou ME(1), Stathopoulou N(3), Andrianopoulou P(3), Kapsokefalou M(2), Bountziouka V(1)(4)(5), Kolomvotsou A(6), Prapa I(7), Mitropoulou G(7), Pavlatou C(7), Tzakos AG(8), Panas P(9), Kourkoutas Y(7), Koutelidakis AE(1). Author information: (1)Laboratory of Nutrition and Public Health, Department of Food Science and Nutrition, University of the Aegean, 81400 Myrina, Greece. (2)Department of Food Science and Human Nutrition, Agricultural University of Athens, 11855 Athens, Greece. (3)Agia Eleni-Spiliopoulio Pathological Hospital, 11521 Athens, Greece. (4)Cardiovascular Research Centre, Department of Cardiovascular Science, University of Leicester, Leicester LE1 7RH, UK. (5)Population, Policy and Practice Research, GOS Institute of Child Health, University College London, London WC1N 1EH, UK. (6)Polykliniki, Olympiako Chorio, 13677 Acharnes, Greece. (7)Laboratory of Applied Microbiology and Biotechnology, Department of Molecular Biology and Genetics, Democritus University of Thrace, 68100 Alexandroupolis, Greece. (8)Laboratory of Organic Chemistry, Department of Chemistry, University of Ioannina, 45110 Ioannina, Greece. (9)QLC, 26442 Patras, Greece. Background and Objectives: The development of non-dairy probiotic products is a challenge for the food industry, while cereals, as probiotic carriers, provide the means to incorporate probiotics, prebiotics, and fiber into the human diet. The present study investigated the effects of Lactococcus cremoris spp. immobilized on oat flakes on blood and urine biomarkers in a randomized placebo-controlled single-blind clinical trial. Materials and Methods: Fifty-four eligible participants were randomized into a placebo or probiotic group that consumed 5 g of oat flakes daily for 12 weeks. Blood and urine samples were collected at the baseline, 6 weeks, and 12 weeks to assess the glycemic, lipemic, inflammatory, immunological, and antioxidant biomarkers, as well as the vitamin levels. Results: The intervention group exhibited a significant reduction in their hs-CRP levels (p = 0.002) and a trend toward decreased IL-6 levels (p = 0.035) at week 12 compared to the control group, suggesting a potential anti-inflammatory effect. Additionally, a significant reduction in insulin levels was observed in the probiotic group at week 6, with a clinical trend toward differentiation despite the absence of statistically significant differences between the groups. Furthermore, there were promising results regarding certain biomarkers, such as vitamin B12 and cortisol levels, in the probiotic group. Conclusions: The twelve-week consumption of Lactococcus cremoris spp. immobilized on oat flakes resulted in improvements in inflammatory, metabolic, and stress-related biomarkers. These results support the examined concept of non-dairy probiotic products, though further research is needed to confirm their efficacy and clarify their underlying mechanisms. DOI: 10.3390/medicina61060956 PMCID: PMC12195460 PMID: 40572644 [Indexed for MEDLINE] Conflict of interest statement: QLC company had the role of coordinating the study procedures within the framework of the FOODBIMES research program and the authors were not employees of the company. The other authors have no conflicts of interest.

A randomised controlled trial of the effects of Galacto-Oligosaccharides on the gut brain-axis of young females.

9. Brain Behav Immun. 2025 Oct;129:573-584. doi: 10.1016/j.bbi.2025.06.020. Epub 2025 Jun 16. A randomised controlled trial of the effects of Galacto-Oligosaccharides on the gut brain-axis of young females. Johnstone N(1), Cohen Kadosh K(2). Author information: (1)School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: nicola.johnstone@surrey.ac.uk. (2)School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: k.cohenkadosh@surrey.ac.uk. Galacto-oligosaccharides (GOS) are prebiotics that modulate gut microbiota and are implicated in the gut-brain axis (GBA), with preclinical models reporting effects on neurochemistry, brain function, and cognition. Here we report the results of a randomised, double-blind, placebo-controlled trial in 83 healthy females (17-25 years), who received GOS or placebo for 28 days. Assessments occurred at baseline, endline, and 28 days post-supplementation. The primary outcome was trait anxiety, secondary outcomes were brain-based levels of GABA and glutamate in the dorsolateral prefrontal cortex (dlPFC), anterior cingulate cortex, and inferior occipital gyrus (IOG) (measured with 1H-MRS), and gut microbiome composition. Tertiary outcomes included social anxiety, depression, emotion behaviour, reaction times, and nutritional intake. Analyses included intention-to-treat, per-protocol, and sensitivity approaches. Trait anxiety did not differ between groups at endline (p = 0.443), though trends favoured lower anxiety in the GOS group at follow-up (p = 0.069). GOS reduced GABA at trend significance in the IOG (p = 0.053) in the Intention to Treat (ITT) population and dlPFC (p = 0.088) in high-anxious participants, with effects persisting at follow-up. GOS transiently increased Bifidobacterium abundance (p = 0.001) but did not affect microbiome diversity. Tertiary outcomes showed no significant changes in social anxiety or depression but faster reaction rates in high-anxious participants for simple (p = 0.036) and choice tasks (p < 0.001). Nutritional intake was unaffected. While GOS supplementation did not significantly reduce trait anxiety, it produced neurochemical changes and transient modulations of the gut microbiome in Bifidobacterium abundance, indicating GOS-induced changes can be traced along the GBA. Copyright © 2025 Elsevier Inc. All rights reserved. DOI: 10.1016/j.bbi.2025.06.020 PMID: 40532960 [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.

Bifidogenic Effect of 2'-Fucosyllactose (2'-FL) on the Gut Microbiome of Healthy Formula-Fed Infants: A Randomized Clinical Trial.

10. Nutrients. 2025 Mar 11;17(6):973. doi: 10.3390/nu17060973. Bifidogenic Effect of 2'-Fucosyllactose (2'-FL) on the Gut Microbiome of Healthy Formula-Fed Infants: A Randomized Clinical Trial. Lazarini T(1), Tonon KM(2), Araujo Filho HB(3), Morais MB(1)(3). Author information: (1)Nutrition Postgraduate Program, Universidade Federal de São Paulo, São Paulo 04023-062, Brazil. (2)Department of Environmental & Public Health Sciences, University of Cincinnati College of Medicine, Cincinnati, OH 45267, USA. (3)Division of Pediatric Gastroenterology, Universidade Federal de São Paulo, São Paulo 04023-062, Brazil. Breast milk is rich in bioactive components, especially human milk oligosaccharides (HMOs), which are crucial for establishing gut microbiota. The 2'-FL (2-Fucosyllactose), one of the most abundant oligosaccharides in breast milk, functions as a selective prebiotic. Objective: To examine the effect of adding 2'-FL (2-Fucosyllactose) to an infant formula containing prebiotic galacto-oligosaccharides (GOSs) and fructo-oligosaccharides (FOSs) on the gut microbiome of healthy formula-fed infants. Methods: This study enrolled infants from three groups: an HMO experimental group (n = 29), a GOS/FOS control group (n = 30), and an exclusively breastfed (breast milk [BM]) reference group (n = 28). Fecal samples from the three groups in the first and fourth months of life were analyzed. The V3 and V4 regions of the 16S rRNA gene were amplified and sequenced on the Illumina MiSeq. ANOVA, Kruskal-Wallis, richness indices (Chao1, Shannon), UniFrac distances, and the Adonis tests were used to perform statistical analyses on the relative abundance of phyla and genera, as well as the alpha and beta-diversity of the gut microbiota. Results: After intervention, Actinobacteriota emerged as the predominant phylum in both the HMO (60.4%) and BM (46.6%) groups. Bifidobacterium and Escherichia-Shigella were identified as the two most abundant bacterial genera in both groups. Nevertheless, the statistical analysis showed that the relative abundance of Bifidobacterium in the HMO formula-fed group after intervention was similar to that in the BM group (p > 0.05). Infants in the HMO and GOS/FOS groups showed higher relative abundance of [Ruminococcus]_gnavus_group bacteria compared to those in the BM group. Groups fed with infant formula demonstrated higher alpha-diversity of gut microbiota compared to breastfed infants (p < 0.05), at the time of admission as well as after the intervention. Beta-diversity was significantly different among the three groups, according to type of feeding. Infants fed a 2'-FL-supplemented infant formula exhibited growth comparable to that of breastfed infants throughout the intervention period, demonstrating that the formula was both safe and well tolerated. Conclusions: Adding 2'-FL to an infant formula containing 4 g/L of GOS + FOS resulted in a stronger bifidogenic effect compared to the formula without 2'-FL. DOI: 10.3390/nu17060973 PMCID: PMC11944528 PMID: 40290019 [Indexed for MEDLINE] Conflict of interest statement: T.L. and K.M.T. are the former employees of Nestlé Nutrition, Brazil. All other authors report no conflict of interests concerning this research.

Indicators of improved emotion behavior in 6-14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent.

11. Nutr J. 2025 Mar 1;24(1):34. doi: 10.1186/s12937-025-01098-5. Indicators of improved emotion behavior in 6-14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent. Johnstone N(1), Cohen Kadosh K(2). Author information: (1)School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK. nicola.johnstone@surrey.ac.uk. (2)School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, GU2 7XH, UK. k.cohenkadosh@surrey.ac.uk. BACKGROUND: In this double-blind placebo-controlled randomised intervention we investigated the potential benefits of a prebiotic supplement on children's well-being in a home setting. The primary aim was to determine if this supplement could effectively reduce anxiety, improve mood, and enhance cognitive function, similar to findings in young adults. METHODS: Fifty-three healthy children, aged 6 to 14, participated in an 8-week trial. The trial consisted of three testing time points; day zero marked the baseline measurement (T1) followed by a 28-day supplement intervention period during which they consumed 5.5 g of the prebiotic galactooligosaccharides (GOS) daily under parental guidance. Endline measures (T2) were conducted on the last day of supplement consumption, with a final follow-up testing session (T3) on day 56. Primary outcomes were trait anxiety using a questionnaire and emotional behavior in a dot-probe task on responses to positive and negative images. Secondary outcomes encompassed depression levels, cognitive function tests, and dietary intake recorded in a 4-day food diary. Additionally, we explored whether parents' emotional behavior had an impact on children's responses. RESULTS: While our statistical analysis did not reveal significant effects of GOS, there were noteworthy trends. Trait anxiety levels decreased over time in both groups, with a more pronounced decrease in the GOS group (after intervention, p =.090; after follow-up, p =.031). The GOS group exhibited reduced negative emotional responses compared to the placebo group (p =.105), and post-trial depression levels decreased in the GOS group over time (p =.015). Although parental emotional responses correlated with various emotional outcomes in children, they did not influence the intervention effects. CONCLUSIONS: These findings suggest positive trends in line with our hypotheses, however further investigation with greater statistical power would be beneficial. TRIAL REGISTRATION: Retrospectively registered on https://clinicaltrials.gov/ [NCT06258135] on February 6, 2024. © 2025. The Author(s). DOI: 10.1186/s12937-025-01098-5 PMCID: PMC11871729 PMID: 40025494 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: This study received favorable ethical opinion from the University of Surrey ethics committee. Participating parents provided written informed consent as parents/guardians and for individual participation. Children provided assent prior to study participation. Competing interests: The authors declare that they have no competing interests.

Prebiotics Beyond the Gut: Omics Insights, Artificial Intelligence, and Clinical Trials in Organ-Specific Applications.

12. Probiotics Antimicrob Proteins. 2025 Aug;17(4):2500-2521. doi: 10.1007/s12602-025-10465-x. Epub 2025 Jan 29. Prebiotics Beyond the Gut: Omics Insights, Artificial Intelligence, and Clinical Trials in Organ-Specific Applications. Al-Adham ISI(1), Agha ASAA(2), Al-Akayleh F(3), Al-Remawi M(3), Jaber N(4), Al Manasur M(3), Collier PJ(5). Author information: (1)Faculty of Pharmacy and Medical Sciences, University of Petra, Amman, 11196, Jordan. ialadham@uop.edu.jo. (2)School of Pharmacy, Department of Pharmaceutical Sciences, The University of Jordan, Amman, 11942, Jordan. (3)Faculty of Pharmacy and Medical Sciences, University of Petra, Amman, 11196, Jordan. (4)Faculty of Pharmacy, Al Zaytoonah University of Jordan, Amman, 11733, Jordan. (5)Faculty of Pharmacy and Medical Sciences, University of Petra, Amman, 11196, Jordan. pip.collier@yahoo.com. Prebiotics, traditionally linked to gut health, are increasingly recognized for their systemic benefits, influencing multiple organ systems through interactions with the gut microbiota. Compounds like inulin, fructooligosaccharides (FOS), and galactooligosaccharides (GOS) enhance short-chain fatty acid (SCFA) production, benefiting neurocognitive health, cardiovascular function, immune modulation, and skin integrity. Advances in biotechnology, including deep eutectic solvents (DES) for extraction and machine learning (ML) for personalized formulations, have expanded prebiotic applications. Integrating these innovations with "omics" technologies enables precise microbial modulation, fostering personalized nutrition and precision therapies. This review examines organ-specific effects of prebiotics, highlights findings from clinical trials, and explores biotechnological innovations that enhance prebiotic efficacy, laying the groundwork for future personalized therapeutic strategies. © 2025. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. DOI: 10.1007/s12602-025-10465-x PMID: 39878922 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Competing Interests: The authors declare no competing interests.

Efficacy of myo-inositol and zinc on insulin resistance in a paediatric population with obesity.

13. Diabetes Obes Metab. 2025 Apr;27(4):1932-1939. doi: 10.1111/dom.16185. Epub 2025 Jan 9. Efficacy of myo-inositol and zinc on insulin resistance in a paediatric population with obesity. Antoniotti V(1), Partenope C(2), Solito A(2), Mancioppi V(2), Baima J(1), Medina F(2), Dimarakis S(2), Agostini A(3), Sista MT(3), Monzani A(2), Scotti L(4), Rabbone I(2), Prodam F(2)(5), Bellone S(2). Author information: (1)Department of Health Sciences, Università del Piemonte Orientale, Novara, Italy. (2)Unit of Pediatrics Department of Health Sciences, Università del Piemonte Orientale, Novara, Italy. (3)Research and Development, DIFASS International S.p.a, Rimini, Italy. (4)Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy. (5)Endocrinology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy. AIM: To assess the efficacy of the combined administration of myo-inositol and zinc, a mineral involved in the insulin pathway, in paediatric obesity with insulin resistance on HOMA-IR, glucose-insulin metabolism, and lipid profile. MATERIALS AND METHODS: Double-blind, randomized, placebo-controlled study conducted in North Italy. Fifty-six patients (10-18 years, Tanner stage ≥3) with obesity and insulin resistance were randomized to myo-inositol (2000 mg), zinc gluconate (5 mg), and galactooligosaccharides (GOS) from plant-based origin (1000 mg) (TRT) or placebo (PLC) containing only GOS from plant-based origin (1000 mg). All patients received an isocaloric diet following the Mediterranean diet style. Data were collected at baseline (V0) and after 3 months (V1). The primary outcome was the insulin resistance index (HOMA-IR). RESULTS: Fifty out of 56 recruited subjects completed the study. TRT improved HDL cholesterol level compared to PLC (p = 0.05) but not insulin resistance. A stratified post hoc analysis was performed by sex, BMI, and subgroups of adherence to the Mediterranean diet. Subjects were divided for obesity grade, fasting insulin (p = 0.0137) and HOMA-IR (p = 0.0273) were lower in TRT than in PLC patients, with a greater effect on severe obesity. No adverse events were detected. CONCLUSION: Three months of supplementation with myo-inositol and zinc were beneficial on lipid profile and in managing obesity complications at least in subjects with severe phenotype. Thus, myo-inositol and zinc could be used as non-pharmacological agents. This work suggests a long-term study with a larger sample size to enrich the findings. © 2025 John Wiley & Sons Ltd. DOI: 10.1111/dom.16185 PMID: 39781581 [Indexed for MEDLINE]

Effects of synbiotics surpass probiotics alone in improving type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial.

14. Clin Nutr. 2025 Jan;44:248-258. doi: 10.1016/j.clnu.2024.11.042. Epub 2024 Dec 5. Effects of synbiotics surpass probiotics alone in improving type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled trial. Zhang C(1), Zhang Q(1), Zhang X(1), Du S(2), Zhang Y(3), Wang X(4), Liu Y(3), Fang B(1), Chen J(5), Liu R(1), Hao Y(5), Li Y(1), Wang P(1), Zhao L(5), Feng H(6), Zhu L(1), Chen L(7), Chen S(8), Wang F(9), Jiang Z(10), Ji Y(11), Xiao R(12), Wang R(13), He J(14). Author information: (1)Department of Nutrition and Health, Key Laboratory of Functional Dairy, Co-constructed by Ministry of Education and Beijing Government, China Agricultural University, Beijing 100193, China. (2)Mengniu Hi-Tech Dairy Product Beijing Co., Ltd., Beijing 101100, China. (3)Department of Nutrition, The first medical Center of PLA General Hospital, Beijing 100039, China. (4)Department of Obstetrics and Gynecology, Columbia University, New York 10032, USA. (5)Research Center for Probiotics, China Agricultural University, Beijing 100193, China. (6)Research Center for Probiotics, China Agricultural University, Beijing 100193, China; Hebei Engineering Research Center of Animal Product, Langfang 065200, China. (7)Food Laboratory of Zhongyuan, Luohe 462300, China. (8)School of Food and Bioengineering, Henan University of Science and Technology, Luoyang 471003, China. (9)Tibet Tianhong Science and Technology Co., Ltd., Xizang 850000, China. (10)Key Laboratory of Food Bioengineering (China National Light Industry), College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China. (11)Center for Mitochondrial Genetics and Health, Greater Bay Area Institute of Precision Medicine (Guangzhou), Fudan University, Guangzhou 511458, China; School of Life Sciences, Fudan University, Shanghai 200433, China. (12)Mengniu Hi-Tech Dairy Product Beijing Co., Ltd., Beijing 101100, China. Electronic address: xiaoran881230@163.com. (13)Research Center for Probiotics, China Agricultural University, Beijing 100193, China. Electronic address: wangran@cau.edu.cn. (14)Department of Nutrition and Health, Key Laboratory of Functional Dairy, Co-constructed by Ministry of Education and Beijing Government, China Agricultural University, Beijing 100193, China. Electronic address: hejingjing89@cau.edu.cn. BACKGROUND AND AIMS: Combining probiotics and prebiotics in synbiotics may present a synergistic approach to improve type 2 diabetes mellitus (T2DM); however, further evidence is required to establish the comparative efficacy of synbiotics versus probiotics. This study aimed to evaluate the effects of Bifidobacterium animalis subsp. lactis MN-Gup (MN-Gup) and a synbiotic mixture of MN-Gup and galactooligosaccharide (MN-Gup-GOS) on glycemic control in T2DM patients and explore possible mechanisms. METHODS: This randomized, double-blind, placebo-controlled clinical trial assigned 120 T2DM patients, to receive MN-Gup, MN-Gup-GOS, or placebo intervention for 12 weeks. The primary outcome was fasting blood glucose (FBG), with secondary outcomes including hemoglobin A1C (HbA1C), insulin, homeostatic model assessment of insulin resistance (HOMA-IR), inflammatory indicators, oxidative stress indicators, gastrointestinal hormones, gut microbiota, and bile acids (BAs). RESULTS: The median age of the 120 participants was 59 years (interquartile range: 55-62 years), with 40 being men. Compared to baseline, all three groups exhibited significant reductions in FBG. Additionally, the MN-Gup-GOS group demonstrated significant decreases in HbA1c, serum insulin, and HOMA-IR after intervention, whereas no such reductions were observed in the placebo and MN-Gup groups. Regarding the between-group comparisons, the MN-Gup-GOS intervention showed a significantly greater reduction in FBG compared to the placebo (least squares mean difference [95 % CI], -0.69 [-1.29, -0.10] mmol/L, P = 0.022) and MN-Gup (-0.59 [-1.17, -0.01], P = 0.047) group, but not for other indicators of glucose metabolism. Additionally, MN-Gup and MN-Gup-GOS intervention, especially the latter, significantly modified inflammation, oxidative stress, gut microbiota, serum BAs, and GLP-1 levels. Correlation analysis showed significant associations between changes in certain gut microbiota (Bifidobacterium) and BAs (deoxycholic acid and lithocholic acid) with glycemic indicators. CONCLUSIONS: The auxiliary effect of synbiotics MN-Gup-GOS on reducing FBG levels surpassed that of MN-Gup probiotics alone in T2DM patients, potentially attributed to the enhanced modulation of gut microbiota, BAs, and GLP-1 secretion. TRIAL REGISTRATION: This study was registered on the website of www.chictr.org.cn, number ChiCTR2100052187. Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved. DOI: 10.1016/j.clnu.2024.11.042 PMID: 39719724 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest There are no conflicts to declare.

Prebiotics and iron fortification among women of reproductive age group - Is there an association with liver and renal function tests?

15. Cell Mol Biol (Noisy-le-grand). 2024 Nov 27;70(11):52-57. doi: 10.14715/cmb/2024.70.11.7. Prebiotics and iron fortification among women of reproductive age group - Is there an association with liver and renal function tests? Iqbal S(1), Ahmed W(2), Zafar S(3), Farooq U(4), Abid J(5), Ahmad AMR(6). Author information: (1)College of Pharmacy, Al-Ain University, Abu Dhabi Campus, United Arab Emirates. saheriqbal55@gmail.com. (2)Department of Food Science & Human Nutrition, University of Veterinary & Animal Sciences, Lahore-Pakistan . waqas.niaz@uvas.edu.pk. (3)Department of Public Health, Health Services Academy, Islamabad, Pakistan. sairazafar333@gmail.com. (4)Department of Nutrition & Dietetics, National University of Medical Sciences, Rawalpindi, Pakistan. umar.farooq@numspak.edu.pk. (5)Department of Nutrition & Dietetics, National University of Medical Sciences, Rawalpindi, Pakistan. juweria.abid@numspak.edu.pk. (6)Department of Nutrition & Dietetics, National University of Medical Sciences, Rawalpindi, Pakistan. abdul.momin@numspak.edu.pk. Iron fortification compounds are of special interest to treat iron deficiency anemia, however, the dose-response effects of these fortificants on liver and renal functions have not been extensively reported in human subjects. The present study determines the effects of prebiotics and iron fortificants on liver function tests (LFTs) and renal function tests (RFTs) among women of reproductive age (WRA). A double-blind randomized controlled trial was performed for the duration of 90 days. A total of 75 iron-deficient women were selected and randomly divided into 5 groups (4 treatment groups and 1 control group). For this purpose, four different types of fortified wheat flour were prepared using two iron fortificants (NaFeEDTA and FeSO4) and two prebiotics (Inulin and Galacto oligosaccharides) were given to four treatment groups, while control groups were only given iron-fortified flour without the addition of prebiotics. Blood samples were collected every month to evaluate Liver Function Tests, including Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin and Renal Function Tests, including serum urea and creatinine. Our results found that prebiotic and iron-fortified diets increased ALT, AST and total bilirubin levels among WRA. For AST, ALP and total bilirubin, our results found the highest increase in the treatment groups treated with prebiotics and iron fortificants at 963 mg/kg GOS + 15 ppm FeSO4. Moreover, the highest values of ALT and serum creatine were seen in groups treated with 963 mg/kg Inulin + 20 ppm NaFeEDTA, while maximum value for serum urea could be seen in the group given 963 mg/kg GOS + 30 ppm FeSO4. The study concluded that prebiotic and iron-fortified diets increased ALT, AST and total bilirubin levels among WRA. DOI: 10.14715/cmb/2024.70.11.7 PMID: 39707781 [Indexed for MEDLINE]