Status:
COMPLETED
MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Netherlands Heart Foundation
Unilever R&D
Conditions:
Insulin Resistance
Metabolic Syndrome X
Eligibility:
All Genders
40-65 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00405197
Start Date
November 1 2006
End Date
April 1 2007
Last Update
December 12 2007
Active Locations (2)
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1
Hospital Gelderse Vallei
Ede, Netherlands, 6710 HN
2
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands