MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

Study Overview
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Brief Summary
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Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Recently, an intervention study reported that a diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin sensitivity in healthy subjects. However, additional beneficial effects can be expected from the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a typical Mediterranean diet will even have more pronounced effects. Study objectives: To investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks. Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10. Expected results: Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome.

Official Title
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Study on the Effect of Mono-Unsaturated Fatty Acids (MUFA) and the Mediterranean Diet on Hyperinsulinemia and Other Components of the Metabolic Syndrome

Conditions
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Insulin Resistance, Metabolic Syndrome X, Dyslipidemia, Hypertension, Overweight

Intervention / Treatment
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* Behavioral: Isocaloric diet high in MUFA or Mediterranean diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Waist circumference ≥ 94 cm for men or ≥ 80 cm for women Age from 40 to 65 years at the time of randomisation Written informed consent obtained Exclusion Criteria: Unable or unwilling to comply with study procedures. The use of drugs for lowering serum cholesterol, serum triglycerides, blood pressure, or diabetes. Unusual dietary patterns, including high alcohol intakes Recent (< 4 weeks) or current participation in a study with any investigational drug or dietary intervention. High concentrations of total cholesterol (>8 mmol/L). Diabetes mellitus. Being pregnant or giving breastfeeding.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Isocaloric diet high in MUFA or Mediterranean diet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Insulin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic/ diastolic blood pressure |  |  | 
| plasma glucose |  |  | 
| serum HDL-cholesterol |  |  | 
| serum triglycerides |  |  | 
| waist-hip circumference |  |  | 
| serum total cholesterol |  |  | 
| serum LDL-cholesterol |  |  | 
| Blood sample will be stored for measuring markers of inflammation. |  |  | 
| Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp. |  |  | 
| Molecular markers in fat and muscle biopsies |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MUFA, Mediterranean diet, Insulin resistance, metabolic syndrome X