MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

This study has been completed.
Sponsor:
Collaborators:
Netherlands Heart Foundation
Unilever R&D
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00405197
First received: November 28, 2006
Last updated: December 10, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Insulin Resistance
Metabolic Syndrome X
Dyslipidemia
Hypertension
Overweight
Behavioral: Isocaloric diet high in MUFA or Mediterranean diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Study on the Effect of Mono-Unsaturated Fatty Acids (MUFA) and the Mediterranean Diet on Hyperinsulinemia and Other Components of the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Fasting Insulin

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: November 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405197

Locations
Netherlands
Hospital Gelderse Vallei
Ede, Netherlands, 6710 HN
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands
Sponsors and Collaborators
Wageningen University
Netherlands Heart Foundation
Unilever R&D
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00405197     History of Changes
Other Study ID Numbers: NHS 2003B068
Study First Received: November 28, 2006
Last Updated: December 10, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
MUFA
Mediterranean diet
Insulin resistance
metabolic syndrome X

Additional relevant MeSH terms:
Metabolic Syndrome X
Hypertension
Insulin Resistance
Dyslipidemias
Overweight
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014