MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00405197

First Posted: November 29, 2006

Last Update Posted: December 12, 2007

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.

Collaborators:

Netherlands Heart Foundation

Unilever R&D

Information provided by:

Wageningen University

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 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

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): 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:

Esposito K, Marfella R, Ciotola M, Di Palo C, Giugliano F, Giugliano G, D'Armiento M, D'Andrea F, Giugliano D. Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial. JAMA. 2004 Sep 22;292(12):1440-6.

Vessby B, Uusitupa M, Hermansen K, Riccardi G, Rivellese AA, Tapsell LC, Nälsén C, Berglund L, Louheranta A, Rasmussen BM, Calvert GD, Maffetone A, Pedersen E, Gustafsson IB, Storlien LH; KANWU Study. Substituting dietary saturated for monounsaturated fat impairs insulin sensitivity in healthy men and women: The KANWU Study. Diabetologia. 2001 Mar;44(3):312-9.

Panagiotakos DB, Polychronopoulos E. The role of Mediterranean diet in the epidemiology of metabolic syndrome; converting epidemiology to clinical practice. Lipids Health Dis. 2005 Apr 12;4:7. Review.

Serra-Majem L, Roman B, Estruch R. Scientific evidence of interventions using the Mediterranean diet: a systematic review. Nutr Rev. 2006 Feb;64(2 Pt 2):S27-47. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van Dijk SJ, Feskens EJ, Bos MB, de Groot LC, de Vries JH, Müller M, Afman LA. Consumption of a high monounsaturated fat diet reduces oxidative phosphorylation gene expression in peripheral blood mononuclear cells of abdominally overweight men and women. J Nutr. 2012 Jul;142(7):1219-25. doi: 10.3945/jn.111.155283. Epub 2012 May 23.

van Dijk SJ, Feskens EJ, Bos MB, Hoelen DW, Heijligenberg R, Bromhaar MG, de Groot LC, de Vries JH, Müller M, Afman LA. A saturated fatty acid-rich diet induces an obesity-linked proinflammatory gene expression profile in adipose tissue of subjects at risk of metabolic syndrome. Am J Clin Nutr. 2009 Dec;90(6):1656-64. doi: 10.3945/ajcn.2009.27792. Epub 2009 Oct 14.


ClinicalTrials.gov Identifier:	NCT00405197 History of Changes
Other Study ID Numbers:	NHS 2003B068
First Submitted:	November 28, 2006
First Posted:	November 29, 2006
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

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