GOS and Insulin Sensitivity

Maastricht University Medical Center46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Obesity Type 2 Diabetes Mellitus

Interventions

GalactooligosaccharideDIETARY_SUPPLEMENT

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

maltodextrinDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Human Biology, Maastricht University Medical Centre

Maastricht, Netherlands

Outcomes

Primary Outcomes

systemic insulin sensitivity

Time frame: change from baseline at 12 week supplementation

Secondary Outcomes

substrate oxidation and energy expenditure

Time frame: 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

fecal and plasma SCFA concentrations

Time frame: 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

skeletal muscle and adipose tissue gen and protein expression

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

Data from ClinicalTrials.gov

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