Clinical trial NCT01119690: Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Dietary
Cross-Over Study
Lipids
Rapeseed oil
Butter
Milk Fat
Unsaturated Fat
Saturated Fat
Oxidized LDL
Platelet Function
Arterial Elasticity
Lead sponsor: Kanta-Häme Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Linnan Klinikka Oy
name: MTT Agrifood Research Finland
name: Finnish Red Cross Blood Service
First posted: 2010-05-07
Enrollment: 43
Sex: MALE
Minimum age (years): 31
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 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:

Primary outcomes:
measure: Circulating lipids
timeFrame: 6 to 8 weeks
measure: Platelet function
timeFrame: 6 to 8 weeks
measure: Glucose tolerance
timeFrame: 5 hours
Secondary outcomes:
measure: Arterial elasticity
timeFrame: 6 to 8 weeks
measure: Serum triglyceride AUC
timeFrame: 5 hours
measure: Platelet function
timeFrame: 5 hours
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Red Cross Blood Transfusion Service
city: Hämeenlinna
country: Finland
facility: Linnan Klinikka
city: Hämeenlinna
country: Finland
facility: Central Hospital of Kanta-Häme
city: Jokioinen
country: Finland
facility: MTT Agrifood Research Finland
Study officials:
affiliation: Central Hospital of Kanta-Häme
name: Ari K Palomäki, MD PhD
role: STUDY_DIRECTOR
affiliation: Central Hospital of Kanta-Häme
name: Kalevi Oksanen, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.