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

Wageningen University and Research

Status: Completed

Conditions: Microbial Colonization

Treatments: Dietary Supplement: GOS 2; Dietary Supplement: GOS 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05762965

6239229900

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

GOS 1

Experimental group

Description:

Galacto-oligosaccharide

Treatment:

Dietary Supplement: GOS 1

GOS 2

Experimental group

Description:

Galacto-oligosaccharide

Treatment:

Dietary Supplement: GOS 2