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

Study Overview
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Brief Summary
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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
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This randomized, parallel, double-blinded intervention study of 6 weeks will include 92 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.

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

Conditions
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Microbial Colonization

Intervention / Treatment
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* Dietary Supplement: GOS 1
* Dietary Supplement: GOS 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study applies a randomized, parallel, double-blind design of 6 weeks
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOS 1<br>Galacto-oligosaccharide | Dietary Supplement: GOS 1<br>* 1 sachet each morning<br>* Other names: galacto oligosaccharide;|
| Experimental: GOS 2<br>Galacto-oligosaccharide | Dietary Supplement: GOS 2<br>* 1 sachet each morning<br>* Other names: galacto oligosaccharide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| faecal abundance of Bifidobacterium | faecal abundance of Bifidobacterium. | At week -3 (start control) | 
| faecal abundance of Bifidobacterium | faecal abundance of Bifidobacterium. | At week 0 (end control) | 
| faecal abundance of Bifidobacterium | faecal abundance of Bifidobacterium. | At week 3 (end intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal microbiota composition | Gene-based microbiota profiling of faecal samples | At week -3 (start control) | 
| Faecal microbiota composition | Gene-based microbiota profiling of faecal samples | At week 0 (end control) | 
| Faecal microbiota composition | Gene-based microbiota profiling of faecal samples | At week 3 (end intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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galacto-oligosaccharides, prebiotics, microbiota