Obesity, Type 2 Diabetes Mellitus
Conditions
Keywords
Insulin Sensitivity
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.
Interventions
DIETARY_SUPPLEMENTGalactooligosaccharide
The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
DIETARY_SUPPLEMENTmaltodextrin
Sponsors
Top Institute Food and Nutrition
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systemic insulin sensitivity | change from baseline at 12 week supplementation |
Secondary
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed