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Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function (HMS-03)

This study has been completed.
Sponsor:
Collaborators:
Linnan Klinikka, Hämeenlinna, Finland
MTT Agrifood Research Finland
Finnish Red Cross Blood Transfusion Service
Information provided by:
Central Hospital of Kanta-Hame
ClinicalTrials.gov Identifier:
NCT01119690
First received: May 6, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Metabolic Syndrome
 Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO)
Dietary Supplement: milk fat

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central Hospital of Kanta-Hame:

Primary Outcome Measures:
  • Circulating lipids [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
    At the end of both 6- to 8-week dietary periods, fasting values of circulating lipids including oxidized LDL are determined

  • Platelet function [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
    At the end of both 6- to 8-week dietary periods, platelet function is determined

  • Glucose tolerance [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    During a 5-hour oral glucose-fat tolerance test the area under curve of plasma glucose and insulin concentration is determined


Secondary Outcome Measures:
  • Arterial elasticity [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: No ]
    At the end of both 6- to 8-week dietary periods, arterial elasticity is determined

  • Serum triglyceride AUC [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    During a 5-hour oral glucose-fat tolerance test the area under curve of serum triglyceride concentration is determined

  • Platelet function [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    During a 5-hour oral glucose-fat tolerance test the platelet function is determined


Enrollment: 43
Study Start Date: September 2004
Study Completion Date: June 2008
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rapeseed oil Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO)
  1. In the dietary period of 6 to 8 weeks: CTPRO 37 ml/day.
  2. In the 5-hour oral glucose and fat tolerance test: glucose and CTPRO.
Other Name: Virgino
Active Comparator: Milk fat Dietary Supplement: milk fat
  1. In dietary period of 6 to 8 weeks: 37.5 grams of butter.
  2. In the 5-hour oral glucose and fat tolerance test: glucose and cream
Other Name: Valio butter

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.

  Eligibility

Ages Eligible for Study:   31 Years to 66 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119690

Locations
Finland
Finnish Red Cross Blood Transfusion Service
Helsinki, Finland, 00310
Linnan Klinikka
Hämeenlinna, Finland, 13100
Central Hospital of Kanta-Häme
Hämeenlinna, Finland, 13530
MTT Agrifood Research Finland
Jokioinen, Finland, 31600
Sponsors and Collaborators
Central Hospital of Kanta-Hame
Linnan Klinikka, Hämeenlinna, Finland
MTT Agrifood Research Finland
Finnish Red Cross Blood Transfusion Service
Investigators
Study Director: Ari K Palomäki, MD PhD Central Hospital of Kanta-Häme
Study Director: Kalevi Oksanen, MD PhD Central Hospital of Kanta-Häme
  More Information

No publications provided by Central Hospital of Kanta-Hame

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ari Palomäki, MD PhD, Head of department, Central Hospital of Kanta-Häme
ClinicalTrials.gov Identifier: NCT01119690     History of Changes
Other Study ID Numbers: KHMetS-03-AP, HMS-03
Study First Received: May 6, 2010
Last Updated: May 6, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by Central Hospital of Kanta-Hame:
Dietary
Cross-Over Study
Lipids
Rapeseed oil
Butter
Milk Fat
 Unsaturated Fat
Saturated Fat
Oxidized LDL
Platelet Function
Arterial Elasticity

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013