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Search / Trial NCT05762965

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

Launched by WAGENINGEN UNIVERSITY AND RESEARCH · Feb 27, 2023

Trial Information

Current as of May 11, 2025

Completed

Keywords

Galacto Oligosaccharides Prebiotics Microbiota

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

  • 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.

About Wageningen University And Research

Wageningen University & Research (WUR) is a leading institution in the fields of life sciences, agricultural research, and environmental sustainability. With a strong commitment to advancing knowledge and fostering innovation, WUR conducts interdisciplinary research that addresses global challenges related to food security, climate change, and public health. The university collaborates with various stakeholders, including industry, government, and non-profit organizations, to translate research findings into practical solutions. Through its rigorous clinical trials and research initiatives, WUR aims to improve health outcomes and promote sustainable practices, positioning itself as a pivotal player in enhancing the well-being of both people and the planet.

Locations

Wageningen, Gelderland, Netherlands

Patients applied

0 patients applied

Trial Officials

Maartje van den Belt, Msc

Principal Investigator

Wageningen Food and Biobased Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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