MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

NCT00405197 | Completed

• 1 other identifier: NHS 2003B068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Insulin Resistance; Metabolic Syndrome X; Dyslipidemia; Hypertension; Overweight

Keywords

MUFA; Mediterranean diet; Insulin resistance; metabolic syndrome X

Outcome Measures

Primary Outcomes (1)

• Fasting Insulin

Secondary Outcomes (10)

• Systolic/ diastolic blood pressure

• plasma glucose

• serum HDL-cholesterol

• serum triglycerides

• waist-hip circumference

Interventions

Isocaloric diet high in MUFA or Mediterranean diet BEHAVIORAL

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University: lead
• Netherlands Heart Foundation: collaborator
• Unilever R&D: collaborator

Study Sites (2)

Hospital Gelderse Vallei

Ede, 6710 HN, Netherlands

Location

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Location

Related Publications (6)

• 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. doi: 10.1001/jama.292.12.1440.

  PMID: 15383514 BACKGROUND

• Vessby B, Uusitupa M, Hermansen K, Riccardi G, Rivellese AA, Tapsell LC, Nalsen 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. doi: 10.1007/s001250051620.

  PMID: 11317662 BACKGROUND

• 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. doi: 10.1186/1476-511X-4-7.

  PMID: 15826300 BACKGROUND

• 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. doi: 10.1111/j.1753-4887.2006.tb00232.x.

  PMID: 16532897 BACKGROUND

• van Dijk SJ, Feskens EJ, Bos MB, de Groot LC, de Vries JH, Muller 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.

  PMID: 22623392 DERIVED

• van Dijk SJ, Feskens EJ, Bos MB, Hoelen DW, Heijligenberg R, Bromhaar MG, de Groot LC, de Vries JH, Muller 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.

  PMID: 19828712 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome; Dyslipidemias; Hypertension; Overweight

Interventions

Fatty Acids, Monounsaturated; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Unsaturated; Fatty Acids; Lipids; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: November 1, 2006
• Study Completion: April 1, 2007
• Last Updated: December 12, 2007

Record last verified: 2007-12

Locations

NL (2)