Lipids and Insulin Sensitivity

NCT ID: NCT01466816

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Saturated fatty acid test meal

Group Type EXPERIMENTAL

test meals with various fatty acid compositions

Intervention Type DIETARY_SUPPLEMENT

Three different milkshakes with a U13C palmitate tracer added

Monounsaturated fatty acid meal

Group Type EXPERIMENTAL

test meals with various fatty acid compositions

Intervention Type DIETARY_SUPPLEMENT

Three different milkshakes with a U13C palmitate tracer added

Polyunsaturated fatty acid meal

Group Type EXPERIMENTAL

test meals with various fatty acid compositions

Intervention Type DIETARY_SUPPLEMENT

Three different milkshakes with a U13C palmitate tracer added

Interventions

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test meals with various fatty acid compositions

Three different milkshakes with a U13C palmitate tracer added

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen E Blaak, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre +

Locations

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Maastricht University Medical Centre +

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 22338035 (View on PubMed)

Other Identifiers

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08-3-030

Identifier Type: -

Identifier Source: org_study_id