Status:
COMPLETED
Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases (Optim'Oils)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions:
Cardiovascular Diseases
Eligibility:
MALE
30-65 years
Phase:
NA
Brief 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 ...
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: Six...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00852735
Start Date
December 1 2008
End Date
July 1 2009
Last Update
March 10 2010
Active Locations (1)
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1
CRNH Auvergne
Clermont-Ferrand, France, 63000