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

NCT05762965 | Completed

• 1 other identifier: 6239229900
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microbial Colonization

Keywords

galacto-oligosaccharides; prebiotics; microbiota

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Faecal microbiota composition

  At week -3 (start control)

• Faecal microbiota composition

  At week 0 (end control)

• Faecal microbiota composition

  At week 3 (end intervention)

Study Arms (2)

GOS 1

EXPERIMENTAL

Galacto-oligosaccharide

Dietary Supplement: GOS 1

GOS 2

EXPERIMENTAL

Galacto-oligosaccharide

Dietary Supplement: GOS 2

Interventions

GOS 1 DIETARY_SUPPLEMENT

1 sachet each morning

Also known as: galacto oligosaccharide

GOS 1

GOS 2 DIETARY_SUPPLEMENT

1 sachet each morning

Also known as: galacto oligosaccharide

GOS 2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: self-representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy women
• Aged between 40 - 70 year
• Body Mass Index (BMI) between 18.5 - 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University and Research: lead
• FrieslandCampina: collaborator

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, Netherlands

Location

Related Publications (1)

• Looijesteijn E, Schoemaker MH, van den Belt M, Hester ER, Kortman GAM, Viskaal-van Dongen M, Nauta A. A double-blind intervention trial in healthy women demonstrates the beneficial impact on Bifidobacterium with low dosages of prebiotic galacto-oligosaccharides. Front Nutr. 2024 Aug 19;11:1440319. doi: 10.3389/fnut.2024.1440319. eCollection 2024.

  PMID: 39224188 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Interventions

4'-galactooligosaccharide

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maartje van den Belt, Msc

  Wageningen Food and Biobased Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Model Details: The study applies a randomized, parallel, double-blind design of 6 weeks

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 10, 2023
• Study Start: May 12, 2023
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)