MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-04-30

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.

Detailed Description

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Conditions

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Insulin Resistance Metabolic Syndrome X Dyslipidemia Hypertension Overweight

Keywords

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MUFA Mediterranean diet Insulin resistance metabolic syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Isocaloric diet high in MUFA or Mediterranean diet

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes