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 Oy
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Oy
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 August 20, 2014