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

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

Study Overview

• Status: Completed
• Conditions: Microbial Colonization
• Intervention / Treatment: Dietary supplement: GOS 1; Dietary supplement: GOS 2

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands
      • Wageningen University & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GOS 1; Galacto-oligosaccharide	Dietary supplement: GOS 1; 1 sachet each morning; Other Names: galacto oligosaccharide
Experimental: GOS 2; Galacto-oligosaccharide	Dietary supplement: GOS 2; 1 sachet each morning; Other Names: galacto oligosaccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
faecal abundance of Bifidobacterium	faecal abundance of Bifidobacterium.	At week -3 (start control)
faecal abundance of Bifidobacterium	faecal abundance of Bifidobacterium.	At week 0 (end control)
faecal abundance of Bifidobacterium	faecal abundance of Bifidobacterium.	At week 3 (end intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal microbiota composition	Gene-based microbiota profiling of faecal samples	At week -3 (start control)
Faecal microbiota composition	Gene-based microbiota profiling of faecal samples	At week 0 (end control)
Faecal microbiota composition	Gene-based microbiota profiling of faecal samples	At week 3 (end intervention)

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: FrieslandCampina
• Investigators: Principal Investigator: Maartje van den Belt, MSc, Wageningen Food and Biobased Research

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: microbiota; prebiotics; galacto-oligosaccharides
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 6239229900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No