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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Cold-pressed turnip rapeseed oil (CTPRO); Dietary supplement: milk fat

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00310
    • Finnish Red Cross Blood Transfusion Service
  • Hämeenlinna, Finland, 13100
    • Linnan Klinikka
  • Hämeenlinna, Finland, 13530
    • Central Hospital of Kanta-Häme
  • Jokioinen, Finland, 31600
    • MTT Agrifood Research Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 66 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rapeseed oil	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.; Other Names: Virgino
ACTIVE_COMPARATOR: Milk fat	Dietary supplement: 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; Other Names: Valio butter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kanta-Häme Central Hospital
• Collaborators: Linnan Klinikka Oy; Finnish Red Cross Blood Service; MTT Agrifood Research Finland

Publications and helpful links

General Publications

• Saarinen HJ, Husgafvel S, Pohjantahti-Maaroos H, Wallenius M, Palomaki A. Improved insulin sensitivity and lower postprandial triglyceride concentrations after cold-pressed turnip rapeseed oil compared to cream in patients with metabolic syndrome. Diabetol Metab Syndr. 2018 May 4;10:38. doi: 10.1186/s13098-018-0340-7. eCollection 2018.
• Saarinen HJ, Sittiwet C, Simonen P, Nissinen MJ, Stenman UH, Gylling H, Palomaki A. Determining the mechanisms of dietary turnip rapeseed oil on cholesterol metabolism in men with metabolic syndrome. J Investig Med. 2018 Jan;66(1):11-16. doi: 10.1136/jim-2017-000495. Epub 2017 Aug 11.
• Palomaki A, Pohjantahti-Maaroos H, Wallenius M, Kankkunen P, Aro H, Husgafvel S, Pihlava JM, Oksanen K. Effects of dietary cold-pressed turnip rapeseed oil and butter on serum lipids, oxidized LDL and arterial elasticity in men with metabolic syndrome. Lipids Health Dis. 2010 Dec 1;9:137. doi: 10.1186/1476-511X-9-137.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (ACTUAL): April 1, 2005
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 6, 2010
• First Posted (ESTIMATE): May 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): May 7, 2010
• Last Update Submitted That Met QC Criteria: May 6, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Lipids; Arterial Elasticity; Cross-Over Study; Dietary; Platelet Function; Saturated Fat; Rapeseed oil; Butter; Milk Fat; Unsaturated Fat; Oxidized LDL
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: KHMetS-03-AP; HMS-03 (OTHER: Ethics Committee)