MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

December 10, 2007 updated by: Wageningen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Ede, Netherlands, 6710 HN
        • Hospital Gelderse Vallei
      • Wageningen, Netherlands
        • Wageningen University, Division of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting Insulin

Secondary Outcome Measures

Outcome Measure
plasma glucose
Systolic/ diastolic blood pressure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

Unilever R&D
Netherlands Heart Foundation

Investigators

  • Principal Investigator: Edith JM Feskens, Dr., Division of Human Nutrition, Wageningen University
  • Principal Investigator: Jeanne HM de Vries, Dr., Division of Human Nutrition, Wageningen University
  • Principal Investigator: Lisette CP de Groot, Prof., Division of Human Nutrition, Wageningen University
  • Principal Investigator: Lydia A. Afman, Dr., Division of Human Nutrition, Wageningen University
  • Principal Investigator: Michael R. Muller, Prof., Division of Human Nutrition, Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Estimate)

December 12, 2007

Last Update Submitted That Met QC Criteria

December 10, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS 2003B068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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