GOS and Insulin Sensitivity

Study Overview
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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.

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

Conditions
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Obesity, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Galactooligosaccharide
* Dietary Supplement: maltodextrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic insulin sensitivity |  | change from baseline at 12 week supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substrate oxidation and energy expenditure |  | change from baseline at 12 week supplementation | 
| plasma markers of substrate and energy metabolism |  | change from baseline at week 1 and 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Sensitivity