Microbial Colonization Clinical Trial
— DenaliOfficial title:
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
NCT number | NCT05762965 |
Other study ID # | 6239229900 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 12, 2023 |
Est. completion date | July 7, 2023 |
Verified date | February 2024 |
Source | Wageningen University and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.
Status | Completed |
Enrollment | 88 |
Est. completion date | July 7, 2023 |
Est. primary completion date | July 7, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Wageningen University & Research | Wageningen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Wageningen University and Research | FrieslandCampina |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | faecal abundance of Bifidobacterium | faecal abundance of Bifidobacterium. | At week -3 (start control) | |
Primary | faecal abundance of Bifidobacterium | faecal abundance of Bifidobacterium. | At week 0 (end control) | |
Primary | faecal abundance of Bifidobacterium | faecal abundance of Bifidobacterium. | At week 3 (end intervention) | |
Secondary | Faecal microbiota composition | Gene-based microbiota profiling of faecal samples | At week -3 (start control) | |
Secondary | Faecal microbiota composition | Gene-based microbiota profiling of faecal samples | At week 0 (end control) | |
Secondary | Faecal microbiota composition | Gene-based microbiota profiling of faecal samples | At week 3 (end intervention) |
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