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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2024
Source Wageningen University and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
GOS 1
1 sachet each morning
GOS 2
1 sachet each morning

Locations

Country Name City State
Netherlands Wageningen University & Research Wageningen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Wageningen University and Research FrieslandCampina

Country where clinical trial is conducted

Netherlands, 

Outcome

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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