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Completed

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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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Gelderse Vallei, Ede, Netherlands

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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

Isocaloric diet high in MUFA or Mediterranean diet

Behavioral

Primary outcomes

  1. Fasting Insulin

Secondary outcomes

  1. Systolic/ diastolic blood pressure

  2. plasma glucose

  3. serum HDL-cholesterol

  4. serum triglycerides

  5. waist-hip circumference

  6. serum total cholesterol

  7. serum LDL-cholesterol

  8. Blood sample will be stored for measuring markers of inflammation.

  9. Additionally in half of the subjects insulin sensitivity will be measured by the euglycemic hyperinsulinemic clamp.

  10. 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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