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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00405197
Other study ID # NHS 2003B068
Secondary ID
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
Est. primary completion date
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


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
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