Skip to main content
OpenTrials
Completed

NCT Number: NCT05762965

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University & Research

Wageningen, Gelderland, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GOS 1

Dietary Supplement

1 sachet each morning

Other names: galacto oligosaccharide

GOS 2

Dietary Supplement

1 sachet each morning

Other names: galacto oligosaccharide

Primary outcomes

  1. faecal abundance of Bifidobacterium

    Time frame: At week -3 (start control)

    faecal abundance of Bifidobacterium.

  2. faecal abundance of Bifidobacterium

    Time frame: At week 0 (end control)

    faecal abundance of Bifidobacterium.

  3. faecal abundance of Bifidobacterium

    Time frame: At week 3 (end intervention)

    faecal abundance of Bifidobacterium.

Secondary outcomes

  1. Faecal microbiota composition

    Time frame: At week -3 (start control)

    Gene-based microbiota profiling of faecal samples

  2. Faecal microbiota composition

    Time frame: At week 0 (end control)

    Gene-based microbiota profiling of faecal samples

  3. Faecal microbiota composition

    Time frame: At week 3 (end intervention)

    Gene-based microbiota profiling of faecal samples

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • FrieslandCampina

Registry information

Acronym: Denali

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.