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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cold-pressed turnip rapeseed oil (CTPRO)
milk fat
Sponsored by
Kanta-Häme Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Dietary, Cross-Over Study, Lipids, Rapeseed oil, Butter, Milk Fat, Unsaturated Fat, Saturated Fat, Oxidized LDL, Platelet Function, Arterial Elasticity

Eligibility Criteria

31 Years - 66 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

Sites / Locations

  • Finnish Red Cross Blood Transfusion Service
  • Linnan Klinikka
  • Central Hospital of Kanta-Häme
  • MTT Agrifood Research Finland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rapeseed oil

Milk fat

Arm Description

Outcomes

Primary Outcome Measures

Circulating lipids
At the end of both 6- to 8-week dietary periods, fasting values of circulating lipids including oxidized LDL are determined
Platelet function
At the end of both 6- to 8-week dietary periods, platelet function is determined
Glucose tolerance
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
At the end of both 6- to 8-week dietary periods, arterial elasticity is determined
Serum triglyceride AUC
During a 5-hour oral glucose-fat tolerance test the area under curve of serum triglyceride concentration is determined
Platelet function
During a 5-hour oral glucose-fat tolerance test the platelet function is determined

Full Information

First Posted
May 6, 2010
Last Updated
May 6, 2010
Sponsor
Kanta-Häme Central Hospital
Collaborators
Linnan Klinikka Oy, MTT Agrifood Research Finland, Finnish Red Cross Blood Service
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1. Study Identification

Unique Protocol Identification Number
NCT01119690
Brief Title
Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function
Acronym
HMS-03
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kanta-Häme Central Hospital
Collaborators
Linnan Klinikka Oy, MTT Agrifood Research Finland, Finnish Red Cross Blood Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Dietary, Cross-Over Study, Lipids, Rapeseed oil, Butter, Milk Fat, Unsaturated Fat, Saturated Fat, Oxidized LDL, Platelet Function, Arterial Elasticity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapeseed oil
Arm Type
Active Comparator
Arm Title
Milk fat
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Cold-pressed turnip rapeseed oil (CTPRO)
Other Intervention Name(s)
Virgino
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
milk fat
Other Intervention Name(s)
Valio butter
Intervention Description
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
Primary Outcome Measure Information:
Title
Circulating lipids
Description
At the end of both 6- to 8-week dietary periods, fasting values of circulating lipids including oxidized LDL are determined
Time Frame
6 to 8 weeks
Title
Platelet function
Description
At the end of both 6- to 8-week dietary periods, platelet function is determined
Time Frame
6 to 8 weeks
Title
Glucose tolerance
Description
During a 5-hour oral glucose-fat tolerance test the area under curve of plasma glucose and insulin concentration is determined
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Arterial elasticity
Description
At the end of both 6- to 8-week dietary periods, arterial elasticity is determined
Time Frame
6 to 8 weeks
Title
Serum triglyceride AUC
Description
During a 5-hour oral glucose-fat tolerance test the area under curve of serum triglyceride concentration is determined
Time Frame
5 hours
Title
Platelet function
Description
During a 5-hour oral glucose-fat tolerance test the platelet function is determined
Time Frame
5 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari K Palomäki, MD PhD
Organizational Affiliation
Central Hospital of Kanta-Häme
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kalevi Oksanen, MD PhD
Organizational Affiliation
Central Hospital of Kanta-Häme
Official's Role
Study Director
Facility Information:
Facility Name
Finnish Red Cross Blood Transfusion Service
City
Helsinki
ZIP/Postal Code
00310
Country
Finland
Facility Name
Linnan Klinikka
City
Hämeenlinna
ZIP/Postal Code
13100
Country
Finland
Facility Name
Central Hospital of Kanta-Häme
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
Facility Name
MTT Agrifood Research Finland
City
Jokioinen
ZIP/Postal Code
31600
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29755591
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.
Results Reference
derived
PubMed Identifier
28801309
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.
Results Reference
derived
PubMed Identifier
21122147
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.
Results Reference
derived

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

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