Clinical trial NCT01466816: Lipids and Insulin Sensitivity
Official title: Skeletal Muscle Lipid Metabolism and Insulin Sensitivity: Can Dietary Fatty Acid Composition Modulate Muscle Lipid Storage?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Lipid metabolism
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 10
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Obese males aged between 35 and 70 years with insulin resistance.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Acute effect of meals with various fatty acid composition on postprandial insulin sensitivity
timeFrame: the individual participants will be measured within 8-10 weeks.
measure: Acute effect of meals with various fatty acid composition on forearm muscle fatty acid handling
timeFrame: the individual participants will be measured within 8-10 weeks.
Secondary outcomes:
measure: Acute effect of meals with various fatty acid composition on intramuscular fatty acid handling
timeFrame: the individual participants will be measured within 8-10 weeks.
measure: Acute effect of meals with various fatty acid composition on transcriptional regulation of the fatty acid metabolism in skeletal muscle biopsies
timeFrame: the individual participants will be measured within 8-10 weeks.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre +
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre +
name: Ellen E Blaak, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jans A, Konings E, Goossens GH, Bouwman FG, Moors CC, Boekschoten MV, Afman LA, Muller M, Mariman EC, Blaak EE. PUFAs acutely affect triacylglycerol-derived skeletal muscle fatty acid uptake and increase postprandial insulin sensitivity. Am J Clin Nutr. 2012 Apr;95(4):825-36. doi: 10.3945/ajcn.111.028787. Epub 2012 Feb 15.