Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT00852735
Status:
COMPLETED
Last Update Posted:
2010-03-10
First Post:
2009-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases (Optim'Oils)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AU 759 | None | None | View |