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Completed

NCT Number: NCT01119690

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

31 year–66 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Finnish Red Cross Blood Transfusion Service, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold-pressed turnip rapeseed oil (CTPRO)

Dietary Supplement
  • 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.

Other names: Virgino

milk fat

Dietary Supplement
  • 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

Other names: Valio butter

Primary outcomes

  1. Circulating lipids

    Time frame: 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

  2. Platelet function

    Time frame: 6 to 8 weeks

    At the end of both 6- to 8-week dietary periods, platelet function is determined

  3. Glucose tolerance

    Time frame: 5 hours

    During a 5-hour oral glucose-fat tolerance test the area under curve of plasma glucose and insulin concentration is determined

Secondary outcomes

  1. Arterial elasticity

    Time frame: 6 to 8 weeks

    At the end of both 6- to 8-week dietary periods, arterial elasticity is determined

  2. Serum triglyceride AUC

    Time frame: 5 hours

    During a 5-hour oral glucose-fat tolerance test the area under curve of serum triglyceride concentration is determined

  3. Platelet function

    Time frame: 5 hours

    During a 5-hour oral glucose-fat tolerance test the platelet function is determined

Sponsors and collaborators

Lead sponsor

Kanta-Häme Central Hospital

Other Gov

Collaborators

  • Finnish Red Cross Blood Service
  • Linnan Klinikka Oy
  • MTT Agrifood Research Finland

Registry information

Official study 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

Acronym: HMS-03

Important dates

Study start
2004
Primary completion
2005
Study completion
2008
First posted
May 7, 2010
Registry last updated
May 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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