Effect of low dose galacto-oligosaccharides (GOS) on faecal gut microbiota in adult wome
- Conditions
- n.v.t.gut bacteriamicrobiota
- Registration Number
- NL-OMON53648
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 88
- Apparently healthy women (based on screening questionnaire), living in the
surrounding of Wageningen (+50 km )
- Aged between 40 - 70 year
- Body Mass Index (BMI) between 18,5 - 30 kg/m2
- Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease,
Ulcerative colitis, or diagnosed irritable bowel disease;
- 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 or diagnosed constipation;
- Having a food allergy to cow*s milk or being lactose intolerant;
- Reported slimming, medically prescribed or other diets
- Reported weight loss or weight gain of >5kg in the month prior to screening
- Use of 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;
- Abuse 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the absolute abundance of faecal Bifidobacterium. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are faecal microbiota composition. Tertiary<br /><br>Objectives are gastrointestinal (GI) comfort, sleep quality (Athens Insomnia<br /><br>scale), well-being and stress (DASS-21).</p><br>