Microbial Colonization
Conditions
Keywords
galacto-oligosaccharides, prebiotics, microbiota
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.
Interventions
DIETARY_SUPPLEMENTGOS 1
1 sachet each morning
DIETARY_SUPPLEMENTGOS 2
1 sachet each morning
Sponsors
FrieslandCampina
Wageningen University and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The study applies a randomized, parallel, double-blind design of 6 weeks
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| faecal abundance of Bifidobacterium | At week -3 (start control) | faecal abundance of Bifidobacterium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Faecal microbiota composition | At week -3 (start control) | Gene-based microbiota profiling of faecal samples |
Countries
Netherlands
Outcome results
None listed