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Sponsors and Collaborators: |
Wageningen University Netherlands Heart Foundation Unilever |
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Information provided by: | Wageningen University |
ClinicalTrials.gov Identifier: | NCT00405197 |
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.
Condition | Intervention |
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Insulin Resistance Metabolic Syndrome X Dyslipidemia Hypertension Overweight |
Behavioral: Isocaloric diet high in MUFA or Mediterranean diet |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Study Completion Date: | April 2007 |
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Hospital Gelderse Vallei | |
Ede, Netherlands, 6710 HN | |
Wageningen University, Division of Human Nutrition | |
Wageningen, Netherlands |
Principal Investigator: | Edith JM Feskens, Dr. | Division of Human Nutrition, Wageningen University |
Principal Investigator: | Jeanne HM de Vries, Dr. | Division of Human Nutrition, Wageningen University |
Principal Investigator: | Lisette CP de Groot, Prof. | Division of Human Nutrition, Wageningen University |
Principal Investigator: | Lydia A. Afman, Dr. | Division of Human Nutrition, Wageningen University |
Principal Investigator: | Michael R. Muller, Prof. | Division of Human Nutrition, Wageningen University |
Study ID Numbers: | NHS 2003B068 |
Study First Received: | November 28, 2006 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00405197 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
MUFA Mediterranean diet Insulin resistance metabolic syndrome X |
Metabolic Syndrome X Metabolic Diseases Vascular Diseases Overweight Insulin Body Weight Hyperinsulinism Signs and Symptoms Infectious Mononucleosis |
Syndrome X Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Abdominal obesity metabolic syndrome Dyslipidemias Hypertension Lipid Metabolism Disorders |
Pathologic Processes Disease Syndrome Cardiovascular Diseases |