MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

Wageningen University

Status

Completed

Conditions

Hypertension

Overweight

Insulin Resistance

Dyslipidemia

Metabolic Syndrome X

Treatments

Behavioral: Isocaloric diet high in MUFA or Mediterranean diet

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00405197

NHS 2003B068

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.