Clinical trial NCT00405197: MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Metabolic Syndrome X
Dyslipidemia
Hypertension
Overweight
Keywords: MUFA
Mediterranean diet
Insulin resistance
metabolic syndrome X
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
name: Unilever R&D
First posted: 2006-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Fasting Insulin
Secondary outcomes:
measure: Systolic/ diastolic blood pressure
measure: plasma glucose
measure: serum HDL-cholesterol
measure: serum triglycerides
measure: waist-hip circumference
measure: serum total cholesterol
measure: serum LDL-cholesterol
measure: Blood sample will be stored for measuring markers of inflammation.
measure: Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp.
measure: Molecular markers in fat and muscle biopsies
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: Hospital Gelderse Vallei
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: Division of Human Nutrition, Wageningen University
name: Edith JM Feskens, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Human Nutrition, Wageningen University
name: Jeanne HM de Vries, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Human Nutrition, Wageningen University
name: Lisette CP de Groot, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Human Nutrition, Wageningen University
name: Lydia A. Afman, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Human Nutrition, Wageningen University
name: Michael R. Muller, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.