GOS and Insulin Sensitivity

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Dietary Supplement: Galactooligosaccharide; Dietary Supplement: maltodextrin

• Registration Number: NCT02271776
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galactooligosaccharide	Galactooligosaccharide	5g 3x per day for 12 weeks
maltodextrin	maltodextrin	3x per day for 12 weeks (isocaloric to intervention)

Primary Outcome Measures

Name	Time	Method
systemic insulin sensitivity	change from baseline at 12 week supplementation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Human Biology, Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands