Clinical trial NCT05762965: Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
Official title: Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Keywords: galacto-oligosaccharides
prebiotics
microbiota
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: FrieslandCampina
First posted: 2023-03-10
Enrollment: 88
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study applies a randomized, parallel, double-blind design of 6 weeks
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: faecal abundance of Bifidobacterium
timeFrame: At week -3 (start control)
measure: faecal abundance of Bifidobacterium
timeFrame: At week 0 (end control)
measure: faecal abundance of Bifidobacterium
timeFrame: At week 3 (end intervention)
Secondary outcomes:
measure: Faecal microbiota composition
timeFrame: At week -3 (start control)
measure: Faecal microbiota composition
timeFrame: At week 0 (end control)
measure: Faecal microbiota composition
timeFrame: At week 3 (end intervention)
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
affiliation: Wageningen Food and Biobased Research
name: Maartje van den Belt, Msc
role: PRINCIPAL_INVESTIGATOR
References: