Lipids and Insulin Sensitivity
- Conditions
- ObesityInsulin Resistance
- Interventions
- Dietary Supplement: test meals with various fatty acid compositions
- Registration Number
- NCT01466816
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
Rationale: The investigators hypothesize that a change in dietary fat quality (an increase in unsaturated fatty acids) may modulate fuel partitioning within the type 2 diabetic muscle towards less accumulation of lipid metabolites and an improved insulin sensitivity.
Objective:
1. The contribution of dietary vs endogenous fat sources to lipid overflow in the circulation and to skeletal muscle lipid uptake and storage in obese insulin resistant subjects vs obese insulin sensitive controls.
2. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on skeletal muscle lipid uptake and storage, fatty acid mediated gene expression and postprandial insulin sensitivity in obese insulin resistant subjects.
Study design: single-blind randomized cross-over trial
Study population: obese males (35-70 years) with or without insulin resistance
Intervention:
1. 1 test meal
2. 3 test meals with a different fatty acid composition
Main study parameters/endpoints:
More insight whether dietary fat quality may modulate circulating lipids and skeletal muscle fatty acids handling, and may affect oxidative capacity and lipid storage in parallel to an increased insulin sensitivity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- Obese males aged between 35 and 70 years with insulin resistance.
- History of type 2 diabetes.
- Liver or kidney failure.
- Diseases in which the live expectation is shorter then 5 years.
- The use of experimental medication.
- Diseases/medication use that may have an influence on the glucose tolerance.
- Not to be able to understand the study information.
- Users of fatty acid supplements including fish oils etc.
- Users of high doses of antioxidant vitamins.
- Athletes.
- People on a diet of people that are planning to lose weight.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Saturated fatty acid test meal test meals with various fatty acid compositions - Monounsaturated fatty acid meal test meals with various fatty acid compositions - Polyunsaturated fatty acid meal test meals with various fatty acid compositions -
- Primary Outcome Measures
Name Time Method Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity the individual participants will be measured within 8-10 weeks. The acute effect of meals with various fatty acid composition ((high saturated (SFA) vs polyunsaturated (PUFA) vs monounsaturated (MUFA)) on postprandial insulin sensitivity will be measured during the stable isotope test.
Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling the individual participants will be measured within 8-10 weeks. Using the stable isotope technique, we can differentiate between the metabolic fate of dietary versus endogenous fatty acids
- Secondary Outcome Measures
Name Time Method Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies the individual participants will be measured within 8-10 weeks. Transcriptional regulation will be measured by means of microarray.
Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling the individual participants will be measured within 8-10 weeks.
Trial Locations
- Locations (1)
Maastricht University Medical Centre +
🇳🇱Maastricht, Limburg, Netherlands