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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2023-07-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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Microbial Colonization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GOS 1

Galacto-oligosaccharide

Group Type EXPERIMENTAL

GOS 1

Intervention Type DIETARY_SUPPLEMENT

1 sachet each morning

GOS 2

Galacto-oligosaccharide

Group Type EXPERIMENTAL

GOS 2

Intervention Type DIETARY_SUPPLEMENT

1 sachet each morning

Interventions

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GOS 1

1 sachet each morning

Intervention Type DIETARY_SUPPLEMENT

GOS 2

1 sachet each morning

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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galacto oligosaccharide galacto oligosaccharide

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes