NCT Number: NCT00405197
MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study
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.
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Notify MeKey information
Conditions
Age range
40 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Hospital Gelderse Vallei, Ede, Netherlands
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Fasting Insulin
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Wageningen University
Other
Collaborators
- Netherlands Heart Foundation
- Unilever R&D
Registry information
Official study title
Study on the Effect of Mono-Unsaturated Fatty Acids (MUFA) and the Mediterranean Diet on Hyperinsulinemia and Other Components of the Metabolic Syndrome
Important dates
- Study start
- 2006
- Study completion
- 2007
- First posted
- Nov 29, 2006
- Registry last updated
- Dec 12, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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