Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function

Not Applicable

Completed

• Conditions: Metabolic Syndrome

• Registration Number: NCT01119690
• Lead Sponsor: Kanta-Häme Central Hospital

Brief Summary

In this study, the effects of dietary intake of cold-pressed turnip rapeseed oil (CTPRO) and milk fat are compared in men with metabolic syndrome having already participated in HMS-02 study.

Detailed Description

This open and balanced cross-over study consists of two dietary treatment phases (either Virgino (R) CTPRO or butter) for 6 to 8 weeks. They are separated from each other with an eight-week washout period. At the end of both periods and 12-hour fasting an oral glucose-fat tolerance test is carried out. Except glucose, the test consists cream (after the butter phase) and CTPRO (after the CTPRO phase).

Otherwise, the subjects (n=43) are asked to maintain their normal dietary habits.

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-04
• Study Completion: 2008-06
• Status Verified: 2010-05
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Last Update Submitted: 2010-05-06
• Study First Posted: 2010-05-07
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

• 43 men with metabolic syndrome having already participated in the HMS-02 Study
• Willing to participate in a demanding dietary study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Circulating lipids	6 to 8 weeks	At the end of both 6- to 8-week dietary periods, fasting values of circulating lipids including oxidized LDL are determined
Platelet function	6 to 8 weeks	At the end of both 6- to 8-week dietary periods, platelet function is determined
Glucose tolerance	5 hours	During a 5-hour oral glucose-fat tolerance test the area under curve of plasma glucose and insulin concentration is determined

Secondary Outcome Measures

Name	Time	Method
Arterial elasticity	6 to 8 weeks	At the end of both 6- to 8-week dietary periods, arterial elasticity is determined
Serum triglyceride AUC	5 hours	During a 5-hour oral glucose-fat tolerance test the area under curve of serum triglyceride concentration is determined
Platelet function	5 hours	During a 5-hour oral glucose-fat tolerance test the platelet function is determined

Trial Locations

Locations (4)

Finnish Red Cross Blood Transfusion Service; 🇫🇮 Helsinki, Finland

Linnan Klinikka; 🇫🇮 Hämeenlinna, Finland

Central Hospital of Kanta-Häme; 🇫🇮 Hämeenlinna, Finland

MTT Agrifood Research Finland; 🇫🇮 Jokioinen, Finland