Cardiovascular DiseasesNCT00852735
Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases (Optim'Oils)
A study testing Rapeseed Oil (prevention of cardiovascular diseases) in people with Cardiovascular Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases. Randomised crossover dietary intervention study: The main objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Rapeseed Oil (prevention of cardiovascular diseases)
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Jul 2009
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age : 30 to 65
- Body mass index between 25 and 30 kg/m²
- Weight lower than 110 kg
- Subject considered as normal after clinical examination and medical questionnaire
- Subject giving his written informed consent
- Subject willing to comply with the study procedures
- Affiliated to National Health Insurance
Who cannot join
- Biological results judged abnormal by investigator
- Positive serologies to HIV or HCV
- Previous medical and/or surgery judged by the investigator as incompatible with the study
- Taking medicine: hypocholesterolemic,beta blockers, IEC,
- Diabetes1 and 2
- High blood pressure
Show all 21Show fewer
- Digestive, cardiovascular, renal, liver, tumor or thyroid diseases in the last 5 years
- Infectious or inflammatory diseases in the last 5 years
- Previous heavy intestine surgery (except appendectomy)
- Triglycerides> 4 g/L
- Dyslipidemia: HDL cholesterol< 0.4 g/L or LDL/HDL>6.25
- blood donation done less than 2 month before the start of the study
- Particular diet: vegetarian, vegan...
- Anormal dietary habits
- Consumption of food complements: antioxidant, ...
- intense physical exercise practise (>5 h per week)
- Tobacco, alcohol:more than 30 g of alcohol/day, i.e.3 glasses/day, smoking > 5 cigarettes /day
- No affiliated to National Health Insurance people
- Refusal to sign informed consent
- Refusal to be registered on the National Volunteers Data file
- Currently participating or who having got 4500 E in this year before to have participated in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases
The purpose of this study is to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases.
Randomised crossover dietary intervention study:
The main objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the lipid metabolism of volunteers as compared with the consumption of a "reference" oil.
Post prandial study:
The second objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the biomarkers of oxidative stress during post prandial period as compared with the consumption of a "reference" oil.
Read the detailed description
For both studies, sedentary men between 30 and 65 years of age, with a BMI between 25 and 30, without cardiovascular disorders, will be selected.
Randomised crossover dietary intervention study:
Sixty volunteers will be randomised into 2 groups of 30. The study will last 12weeks. The first 3 weeks will be an adaptation period or "run in". Volunteers will have every day20 g of the reference rapeseed oil and 20 g of the reference oil-based rapeseed margarine. Subsequently, the two groups will follow 2 dietary intervention periods of 3 weeks during which the volunteers will have alternatively either the reference oil/margarine or the optimized oil/margarine. Three weeks of "wash out" will separate the two dietary interventions of the cross over design trial.
Cardiovascular risk and oxidative stress biomarkers will be assessed in plasma at week 0, 3, 6, 9 and 12.
Volunteers will alsoperform dietary surveys at the week 3, 6, 9 and 12.
Post prandial study:
16 volunteers will be cast lots among the 60 volunteers. They will be randomised into 2 groups of 8. The first kinetic study will be done on week 3. 8 subjects will take 66 g of reference oil and 8 subjects will take 66 g of the optimized oil. 5 blood samples (20 mL each) will be taken.
- Conditions
- Cardiovascular Diseases
- Being tested
- Rapeseed Oil (prevention of cardiovascular diseases)
- Keywords
- Cardiovascular diseases, Rapeseed oil, Micronutriments, HDL cholesterol, Oxidative stress, Tocopherols, Sterols, Prevention of cardiovascular diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapeseed Oil (prevention of cardiovascular diseases)Dietary supplement
to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-Cholestérol
Measured: study 1
Secondary outcomes (1)
Biomarkers of the oxidative stress every 3 weeks Biomarkers of the oxidative stress during the post prandial period
Measured: every 3 weeks, during the post prandial period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, ITERG, Unilever R&D, Lesieur
- Investigators
- Noël Cano, Principal investigator, Centre de Recherche en Nutrition Humaine d'Auvergne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852735
- Sponsor's protocol ID
- CHU-0047
- Other IDs
- AU 759
- Status last verified
- Mar 2010
- First submitted
- 26 Feb 2009
- Last updated
- 10 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT00852735
- Acronym / sponsor ID
- CHU-0047
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular diseases, Rapeseed oil, Micronutriments, HDL cholesterol, Oxidative stress, Tocopherols, Sterols, Prevention of cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, ITERG, Unilever R&D, Lesieur
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Feb 2009 (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.
The purpose of this study is to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases.
Randomised crossover dietary intervention study:
The main objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the lipid metabolism of volunteers as compared with the consumption of a "reference" oil.
Post prandial study:
The second objective of the clinical study is to investigate the effect of the consumption of an "optimized" rapeseed oil on the biomarkers of oxidative stress during post prandial period as compared with the consumption of a "reference" oil.
Detailed description
For both studies, sedentary men between 30 and 65 years of age, with a BMI between 25 and 30, without cardiovascular disorders, will be selected.
Randomised crossover dietary intervention study:
Sixty volunteers will be randomised into 2 groups of 30. The study will last 12weeks. The first 3 weeks will be an adaptation period or "run in". Volunteers will have every day20 g of the reference rapeseed oil and 20 g of the reference oil-based rapeseed margarine. Subsequently, the two groups will follow 2 dietary intervention periods of 3 weeks during which the volunteers will have alternatively either the reference oil/margarine or the optimized oil/margarine. Three weeks of "wash out" will separate the two dietary interventions of the cross over design trial.
Cardiovascular risk and oxidative stress biomarkers will be assessed in plasma at week 0, 3, 6, 9 and 12.
Volunteers will alsoperform dietary surveys at the week 3, 6, 9 and 12.
Post prandial study:
16 volunteers will be cast lots among the 60 volunteers. They will be randomised into 2 groups of 8. The first kinetic study will be done on week 3. 8 subjects will take 66 g of reference oil and 8 subjects will take 66 g of the optimized oil. 5 blood samples (20 mL each) will be taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male
- Age : 30 to 65
- Body mass index between 25 and 30 kg/m²
- Weight lower than 110 kg
- Subject considered as normal after clinical examination and medical questionnaire
Key exclusion criteria (21 listed)
- Biological results judged abnormal by investigator
- Positive serologies to HIV or HCV
- Previous medical and/or surgery judged by the investigator as incompatible with the study
- Taking medicine: hypocholesterolemic,beta blockers, IEC,
- Diabetes1 and 2
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 |
|---|---|---|
| Rapeseed Oil (prevention of cardiovascular diseases)to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases | Dietary supplement | – |
Primary outcome
HDL-Cholestérol
Time frame: study 1
1 secondary outcome
Biomarkers of the oxidative stress every 3 weeks Biomarkers of the oxidative stress during the post prandial period
Time frame: every 3 weeks, during the post prandial period
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 10 Mar 2010.
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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.
Noël Cano principal investigator
Centre de Recherche en Nutrition Humaine d'Auvergne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapeseed Oil (prevention of cardiovascular diseases) in people with Cardiovascular Diseases, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 8 inclusion and 21 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 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
HDL-Cholestérol (time frame: study 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2010.