Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women

Not Applicable

Completed

• Conditions: Microbial Colonization

• Registration Number: NCT05762965
• Lead Sponsor: Wageningen University and Research

Brief Summary

Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.

Detailed Description

This randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-10
• Study Start: 2023-05-12
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• Apparently healthy women
• Aged between 40 - 70 year
• Body Mass Index (BMI) between 18.5 - 30 kg/m2

Exclusion Criteria

• Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, Ulcerative colitis, or diagnosed irritable bowel syndrome;
• Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy;
• Diagnosed with diabetes mellitus;
• Use of medication that may influence the study results, such as laxatives, lactase preparations, metformin, antibiotics, proton pomp inhibitors, antipsychotics, NSAID's (judged by our research physician);
• Self-perceived and diagnosed constipation;
• Having a food allergy to cow's milk or being lactose intolerant;
• Self-reported slimming, medically prescribed or other diets
• Reported weight loss or weight gain of >5kg in the month prior to screening
• Use of (foods with) pre-, pro-, syn- and/or postbiotics* (should be stopped at least 4 weeks before the start of the study), or other supplements that can influence the study results (to be determined by the medical investigator);
• History of side effects with the use of prebiotic supplements
• Use of antibiotic treatment less than 3 months before start of the study
• Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported);
• Not able to comply with study procedures;
• Use of drugs (should be stopped at least 4 weeks before the study);
• Alcohol intake ≥7 glasses of alcoholic beverages per week, on average
• Participation in another clinical trial at the same time;
• Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research or employee of FrieslandCampina R&D.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
faecal abundance of Bifidobacterium	At week 3 (end intervention)	faecal abundance of Bifidobacterium.

Secondary Outcome Measures

Name	Time	Method
Faecal microbiota composition	At week 3 (end intervention)	Gene-based microbiota profiling of faecal samples

Trial Locations

Locations (1)

Wageningen University & Research; 🇳🇱 Wageningen, Gelderland, Netherlands