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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hämeenlinna Metabolic Syndrome Research Program (HMS): Effects of Dietary Cold-pressed Turnip Rapeseed Oil and Milk Fat on Serum Lipids, Oxidized LDL, Arterial Elasticity and Platelet Function

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO)
* Dietary Supplement: milk fat


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 31 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rapeseed oil<br> | Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO)<br>* In the dietary period of 6 to 8 weeks: CTPRO 37 ml/day. In the 5-hour oral glucose and fat tolerance test: glucose and CTPRO.<br>* Other names: Virgino;|
| Active Comparator: Milk fat<br> | Dietary Supplement: milk fat<br>* In dietary period of 6 to 8 weeks: 37.5 grams of butter. In the 5-hour oral glucose and fat tolerance test: glucose and cream<br>* Other names: Valio butter;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary, Cross-Over Study, Lipids, Rapeseed oil, Butter, Milk Fat, Unsaturated Fat, Saturated Fat, Oxidized LDL, Platelet Function, Arterial Elasticity