GOS and Insulin Sensitivity

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

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Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:

To investigate the effects of a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.

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Detailed Description

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Conditions

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Obesity Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Galactooligosaccharide

5g 3x per day for 12 weeks

Group Type ACTIVE_COMPARATOR

Galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks

maltodextrin

3x per day for 12 weeks (isocaloric to intervention)

Group Type PLACEBO_COMPARATOR

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Galactooligosaccharide

The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Overweight/obese (BMI ≥ 28 kg/m2 \< 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years will be included in the study.

In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. \< 3kg).

Exclusion Criteria

* diabetes mellitus
* gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
* lactose intolerance and other digestive disorders
* cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
* disease with a life expectancy shorter than 5 years
* abuse of products (alcohol consumption \> 15 units/week, or any drugs)
* excessive nicotine use defined as \>20 cigarettes per day

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes