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

NCT00852735 | Completed

• 2 other identifiers: CHU-0047AU 759
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular diseases; Rapeseed oil; Micronutriments; HDL cholesterol; Oxidative stress; Tocopherols; Sterols; Prevention of cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• HDL-Cholestérol

  study 1

Secondary Outcomes (1)

• 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

Interventions

Rapeseed Oil (prevention of cardiovascular diseases) DIETARY_SUPPLEMENT

to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, ...

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• ITERG: collaborator
• Unilever R&D: collaborator
• Lesieur: collaborator

Study Sites (1)

CRNH Auvergne

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Rapeseed Oil

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Noël Cano

  Centre de Recherche en Nutrition Humaine d'Auvergne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 10, 2010

Record last verified: 2010-03

Locations

FR (1)