GOS and Insulin Sensitivity

April 9, 2018 updated by: Maastricht University Medical Center

The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6200MD
        • Department of Human Biology, Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Galactooligosaccharide
5g 3x per day for 12 weeks
Dietary supplement: Galactooligosaccharide
The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
Placebo Comparator: maltodextrin
3x per day for 12 weeks (isocaloric to intervention)
Dietary supplement: maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
systemic insulin sensitivity
Time Frame: change from baseline at 12 week supplementation
change from baseline at 12 week supplementation

Secondary Outcome Measures

Outcome Measure
Time Frame
substrate oxidation and energy expenditure
Time Frame: change from baseline at 12 week supplementation
change from baseline at 12 week supplementation
plasma markers of substrate and energy metabolism
Time Frame: change from baseline at week 1 and at 12 week supplementation
change from baseline at week 1 and at 12 week supplementation
fecal and plasma SCFA concentrations
Time Frame: change from baseline at week 1 and at 12 week supplementation
change from baseline at week 1 and at 12 week supplementation
fecal microbiota composition
Time Frame: change from baseline at week 1 and at 12 week supplementation
change from baseline at week 1 and at 12 week supplementation
skeletal muscle and adipose tissue gen and protein expression
Time Frame: change from baseline at week 1 and at 12 week supplementation
change from baseline at week 1 and at 12 week supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Top Institute Food and Nutrition

Investigators

  • Principal Investigator: Ellen E Blaak, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 143026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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