search
Back to results

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

Primary Purpose

Microbial Colonization

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
GOS 1
GOS 2
Sponsored by
Wageningen University and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Microbial Colonization focused on measuring galacto-oligosaccharides, prebiotics, microbiota

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Wageningen University & ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GOS 1

GOS 2

Arm Description

Galacto-oligosaccharide

Galacto-oligosaccharide

Outcomes

Primary Outcome Measures

faecal abundance of Bifidobacterium
faecal abundance of Bifidobacterium.
faecal abundance of Bifidobacterium
faecal abundance of Bifidobacterium.
faecal abundance of Bifidobacterium
faecal abundance of Bifidobacterium.

Secondary Outcome Measures

Faecal microbiota composition
Gene-based microbiota profiling of faecal samples
Faecal microbiota composition
Gene-based microbiota profiling of faecal samples
Faecal microbiota composition
Gene-based microbiota profiling of faecal samples

Full Information

First Posted
February 8, 2023
Last Updated
March 9, 2023
Sponsor
Wageningen University and Research
Collaborators
FrieslandCampina
search

1. Study Identification

Unique Protocol Identification Number
NCT05762965
Brief Title
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
Acronym
Denali
Official Title
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
July 8, 2023 (Anticipated)
Study Completion Date
July 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University and Research
Collaborators
FrieslandCampina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This randomized, parallel, double-blinded intervention study of 6 weeks will include 92 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
Keywords
galacto-oligosaccharides, prebiotics, microbiota

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study applies a randomized, parallel, double-blind design of 6 weeks
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GOS 1
Arm Type
Experimental
Arm Description
Galacto-oligosaccharide
Arm Title
GOS 2
Arm Type
Experimental
Arm Description
Galacto-oligosaccharide
Intervention Type
Dietary Supplement
Intervention Name(s)
GOS 1
Other Intervention Name(s)
galacto oligosaccharide
Intervention Description
1 sachet each morning
Intervention Type
Dietary Supplement
Intervention Name(s)
GOS 2
Other Intervention Name(s)
galacto oligosaccharide
Intervention Description
1 sachet each morning
Primary Outcome Measure Information:
Title
faecal abundance of Bifidobacterium
Description
faecal abundance of Bifidobacterium.
Time Frame
At week -3 (start control)
Title
faecal abundance of Bifidobacterium
Description
faecal abundance of Bifidobacterium.
Time Frame
At week 0 (end control)
Title
faecal abundance of Bifidobacterium
Description
faecal abundance of Bifidobacterium.
Time Frame
At week 3 (end intervention)
Secondary Outcome Measure Information:
Title
Faecal microbiota composition
Description
Gene-based microbiota profiling of faecal samples
Time Frame
At week -3 (start control)
Title
Faecal microbiota composition
Description
Gene-based microbiota profiling of faecal samples
Time Frame
At week 0 (end control)
Title
Faecal microbiota composition
Description
Gene-based microbiota profiling of faecal samples
Time Frame
At week 3 (end intervention)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self-representation
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maartje van den Belt, Msc
Phone
+31618520632
Email
maartje.vandenbelt@wur.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Lonneke LM Janssen Duijghuijsen, PhD
Phone
31317489390
Email
lonneke.janssenduijghuijsen@wur.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maartje van den Belt, Msc
Organizational Affiliation
Wageningen Food and Biobased Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wageningen University & Research
City
Wageningen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maartje Van den Belt, Msc
Email
maartje.vandenbelt@wur.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs