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

W

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

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

Trial contacts and locations

1

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Central trial contact

Maartje van den Belt, Msc; Lonneke LM Janssen Duijghuijsen, PhD

Data sourced from clinicaltrials.gov

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