MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study
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ClinicalTrials.gov Identifier: NCT00405197 |
Recruitment Status
:
Completed
First Posted
: November 29, 2006
Last Update Posted
: December 12, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insulin Resistance Metabolic Syndrome X Dyslipidemia Hypertension Overweight | Behavioral: Isocaloric diet high in MUFA or Mediterranean diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
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 |
Study Start Date : | November 2006 |
Actual Study Completion Date : | April 2007 |

- Fasting Insulin
- 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

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Ages Eligible for Study: | 40 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405197
Netherlands | |
Hospital Gelderse Vallei | |
Ede, Netherlands, 6710 HN | |
Wageningen University, Division of Human Nutrition | |
Wageningen, Netherlands |
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:
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 |
First Posted: | November 29, 2006 Key Record Dates |
Last Update Posted: | December 12, 2007 |
Last Verified: | December 2007 |
Keywords provided by Wageningen University:
MUFA Mediterranean diet Insulin resistance metabolic syndrome X |
Additional relevant MeSH terms:
Metabolic Syndrome X Syndrome Overweight Insulin Resistance Dyslipidemias Disease Pathologic Processes |
Body Weight Signs and Symptoms Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Lipid Metabolism Disorders |