Trial record 45 of 2486 for:    hyperinsulinism

MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405197
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : December 12, 2007
Netherlands Heart Foundation
Unilever R&D
Information provided by:
Wageningen University

Brief Summary:
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 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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Fasting Insulin

Secondary Outcome Measures :
  1. Systolic/ diastolic blood pressure
  2. plasma glucose
  3. serum HDL-cholesterol
  4. serum triglycerides
  5. waist-hip circumference
  6. serum total cholesterol
  7. serum LDL-cholesterol
  8. Blood sample will be stored for measuring markers of inflammation.
  9. Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp.
  10. Molecular markers in fat and muscle biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00405197

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
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 automatically indexed to this study by Identifier (NCT Number): 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:
Mediterranean diet
Insulin resistance
metabolic syndrome X

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders