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

Metabolic Syndrome Clinical Trial

— HMS-03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119690
• Other study ID #: KHMetS-03-AP
• Secondary ID: HMS-03
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: May 6, 2010
• Start date: September 2004
• Est. completion date: June 2008

Study information

• Verified date: May 2010
• Source: Central Hospital of Kanta-Hame
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2008
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 31 Years to 66 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Cold-pressed turnip rapeseed oil (CTPRO)
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.
• milk fat
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

Locations

Country	Name	City	State
Finland	Central Hospital of Kanta-Häme	Hämeenlinna
Finland	Linnan Klinikka	Hämeenlinna
Finland	Finnish Red Cross Blood Transfusion Service	Helsinki
Finland	MTT Agrifood Research Finland	Jokioinen

Sponsors (4)

Lead Sponsor	Collaborator
Central Hospital of Kanta-Hame	Finnish Red Cross, Linnan Klinikka Oy, MTT Agrifood Research Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Platelet function	At the end of both 6- to 8-week dietary periods, platelet function is determined	6 to 8 weeks	No
Primary	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	No
Secondary	Arterial elasticity	At the end of both 6- to 8-week dietary periods, arterial elasticity is determined	6 to 8 weeks	No
Secondary	Serum triglyceride AUC	During a 5-hour oral glucose-fat tolerance test the area under curve of serum triglyceride concentration is determined	5 hours	No
Secondary	Platelet function	During a 5-hour oral glucose-fat tolerance test the platelet function is determined	5 hours	No