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OpenTrials
Completed

NCT Number: NCT02271776

GOS and Insulin Sensitivity

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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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Mellitus

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Biology, Maastricht University Medical Centre

Maastricht, 6200MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

galactooligosaccharide

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

Dietary Supplement

Primary outcomes

  1. systemic insulin sensitivity

    Time frame: change from baseline at 12 week supplementation

Secondary outcomes

  1. substrate oxidation and energy expenditure

    Time frame: change from baseline at 12 week supplementation

  2. plasma markers of substrate and energy metabolism

    Time frame: change from baseline at week 1 and at 12 week supplementation

  3. fecal and plasma SCFA concentrations

    Time frame: change from baseline at week 1 and at 12 week supplementation

  4. fecal microbiota composition

    Time frame: change from baseline at week 1 and at 12 week supplementation

  5. skeletal muscle and adipose tissue gen and protein expression

    Time frame: change from baseline at week 1 and at 12 week supplementation

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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