Metabolic SyndromeHMS-03NCT01119690
Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function
A study testing Cold-pressed turnip rapeseed oil (CTPRO) and milk fat in people with Metabolic Syndrome, run by Kanta-Häme Central Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 to 66 years, men only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Cold-pressed turnip rapeseed oil (CTPRO) and milk fat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesFinland
- Study dates
- Sep 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 66 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 43 men with metabolic syndrome having already participated in the HMS-02 Study
- Willing to participate in a demanding dietary study
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Linnan Klinikka
Hämeenlinna, 13100
Central Hospital of Kanta-Häme
Hämeenlinna, 13530
Finnish Red Cross Blood Transfusion Service
Helsinki, 00310
MTT Agrifood Research Finland
Jokioinen, 31600
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Cold-pressed turnip rapeseed oil (CTPRO), milk fat
- Keywords
- Dietary, Cross-Over Study, Lipids, Rapeseed oil, Butter, Milk Fat, Unsaturated Fat, Saturated Fat, Oxidized LDL, Platelet Function, Arterial Elasticity
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-pressed turnip rapeseed oil (CTPRO)Dietary supplement
Also called Virgino
- 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.
milk fatDietary supplement
Also called Valio butter
- 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
| Study group | Role | What they receive |
|---|---|---|
| Rapeseed oil | Active comparator | Not described Receives: Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO) |
| Milk fat | Active comparator | Not described Receives: Dietary Supplement: milk fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating lipids
At the end of both 6- to 8-week dietary periods, fasting values of circulating lipids including oxidized LDL are determined
Measured: 6 to 8 weeks
Platelet function
At the end of both 6- to 8-week dietary periods, platelet function is determined
Measured: 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
Measured: 5 hours
Secondary outcomes (3)
Arterial elasticity
At the end of both 6- to 8-week dietary periods, arterial elasticity is determined
Measured: 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
Measured: 5 hours
Platelet function
During a 5-hour oral glucose-fat tolerance test the platelet function is determined
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startSep 2004
- Primary completionApr 2005
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanta-Häme Central Hospital
- Sponsor type
- Other government
- Collaborators
- Linnan Klinikka Oy, MTT Agrifood Research Finland, Finnish Red Cross Blood Service
- Investigators
- Ari K Palomäki, MD PhD, Study director, Central Hospital of Kanta-HämeKalevi Oksanen, MD PhD, Study director, Central Hospital of Kanta-Häme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119690
- Sponsor's protocol ID
- KHMetS-03-AP
- Other IDs
- HMS-03
- Acronym
- HMS-03
- Status last verified
- May 2010
- First submitted
- 6 May 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29755591Saarinen 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.
PubMed 28801309Palomaki 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.
PubMed 21122147
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01119690
- Acronym / sponsor ID
- HMS-03 / KHMetS-03-AP
- Conditions
- Metabolic Syndrome
- Keywords
- Dietary, Cross-Over Study, Lipids, Rapeseed oil, Butter, Milk Fat, Unsaturated Fat, Saturated Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kanta-Häme Central HospitalOther government
- Collaborators
- Linnan Klinikka Oy, MTT Agrifood Research Finland, Finnish Red Cross Blood Service
- Study start
- Sep 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapeseed oil | Active comparator | Dietary Supplement: Cold-pressed turnip rapeseed oil (CTPRO) |
| Milk fat | Active comparator | Dietary Supplement: milk fat |
Who may qualify
- Ages
- 31 to 66 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 43 men with metabolic syndrome having already participated in the HMS-02 Study
- Willing to participate in a demanding dietary study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold-pressed turnip rapeseed oil (CTPRO)Also: Virgino1. 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. | Dietary supplement | Rapeseed oil |
| milk fatAlso: Valio butter1. 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 | Dietary supplement | Milk fat |
Primary outcome
Circulating lipids
Time frame: 6 to 8 weeks
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
At the end of both 6- to 8-week dietary periods, platelet function is determined
Glucose tolerance
Time frame: 5 hours
During a 5-hour oral glucose-fat tolerance test the area under curve of plasma glucose and insulin concentration is determined
3 secondary outcomes
Arterial elasticity
Time frame: 6 to 8 weeks
Serum triglyceride AUC
Time frame: 5 hours
Platelet function
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
- Derived from this study: PubMed 29755591Saarinen 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.
- Derived from this study: PubMed 28801309Saarinen 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.
- Derived from this study: PubMed 21122147Palomaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari K Palomäki, MD PhD study director
Central Hospital of Kanta-Häme
Kalevi Oksanen, MD PhD study director
Central Hospital of Kanta-Häme
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold-pressed turnip rapeseed oil (CTPRO) and milk fat in people with Metabolic Syndrome, run by Kanta-Häme Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating lipids (time frame: 6 to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119690, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.