MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405197
• Other study ID #: NHS 2003B068
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: December 10, 2007
• Start date: November 2006
• Est. completion date: April 2007

Study information

• Verified date: December 2007
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension
• Insulin Resistance
• Metabolic Syndrome X
• Overweight

Intervention

Behavioral:
• Isocaloric diet high in MUFA or Mediterranean diet

Locations

Country	Name	City	State
Netherlands	Hospital Gelderse Vallei	Ede
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Netherlands Heart Foundation, Unilever R&D

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. Review. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Insulin
Secondary	Systolic/ diastolic blood pressure
Secondary	plasma glucose
Secondary	serum HDL-cholesterol
Secondary	serum triglycerides
Secondary	waist-hip circumference
Secondary	serum total cholesterol
Secondary	serum LDL-cholesterol
Secondary	Blood sample will be stored for measuring markers of inflammation.
Secondary	Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp.
Secondary	Molecular markers in fat and muscle biopsies