NCT01119690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
Last Updated

May 7, 2010

Status Verified

May 1, 2010

Enrollment Period

7 months

First QC Date

May 6, 2010

Last Update Submit

May 6, 2010

Conditions

Metabolic Syndrome

Keywords

DietaryCross-Over StudyLipidsRapeseed oilButterMilk FatUnsaturated FatSaturated FatOxidized LDLPlatelet FunctionArterial Elasticity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Arterial elasticity

    6 to 8 weeks

  • Serum triglyceride AUC

    5 hours

  • Platelet function

    5 hours

Study Arms (2)

Rapeseed oil

ACTIVE COMPARATOR
Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO)

Milk fat

ACTIVE COMPARATOR
Dietary Supplement: milk fat

Interventions

Cold-pressed turnip rapeseed oil (CTPRO)DIETARY_SUPPLEMENT

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.

Also known as: Virgino
Rapeseed oil
milk fatDIETARY_SUPPLEMENT

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

Also known as: Valio butter
Milk fat

Eligibility Criteria

Age31 Years - 66 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men with metabolic syndrome having already participated in the HMS-02 Study
  • Willing to participate in a demanding dietary study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Linnan Klinikka

Hämeenlinna, 13100, Finland

Location

Central Hospital of Kanta-Häme

Hämeenlinna, 13530, Finland

Location

Finnish Red Cross Blood Transfusion Service

Helsinki, 00310, Finland

Location

MTT Agrifood Research Finland

Jokioinen, 31600, Finland

Location

Related Publications (3)

  • 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.

    PMID: 29755591DERIVED

  • 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.

    PMID: 28801309DERIVED

  • 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.

    PMID: 21122147DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ari K Palomäki, MD PhD

    Central Hospital of Kanta-Häme

    STUDY DIRECTOR

  • Kalevi Oksanen, MD PhD

    Central Hospital of Kanta-Häme

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

September 1, 2004

Primary Completion

April 1, 2005

Study Completion

June 1, 2008

Last Updated

May 7, 2010

Record last verified: 2010-05

Locations

FI(4)