Status:
COMPLETED
GOS and Insulin Sensitivity
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Top Institute Food and Nutrition
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
45-70 years
Phase:
NA
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 ai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02271776
Start Date
October 1 2014
End Date
October 1 2015
Last Update
April 10 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Human Biology, Maastricht University Medical Centre
Maastricht, Netherlands, 6200MD