Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases (Optim'Oils)

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Completed

CT.gov ID

NCT00852735

Collaborator

Centre de Recherche en Nutrition Humaine d'Auvergne (Other), Institut National de la Recherche Agronomique (Other), ITERG (Industry), Unilever R&D (Industry), Lesieur (Industry)

Enrollment

Location

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Dietary Supplement: Rapeseed Oil (prevention of cardiovascular diseases)	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Outcome Measures

Primary Outcome Measures

HDL-Cholestérol [study 1]

Secondary Outcome Measures

Biomarkers of the oxidative stress every 3 weeks Biomarkers of the oxidative stress during the post prandial period [every 3 weeks, during the post prandial period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 Criteria:

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