MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

Not Applicable

Completed

• Conditions: Insulin Resistance; Metabolic Syndrome X; Dyslipidemia; Hypertension; Overweight

• Registration Number: NCT00405197
• Lead Sponsor: Wageningen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-29
• Study Completion: 2007-04
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-10
• Last Update Posted: 2007-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting Insulin

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital Gelderse Vallei; 🇳🇱 Ede, Netherlands

Wageningen University, Division of Human Nutrition; 🇳🇱 Wageningen, Netherlands