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

This study has been completed.
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de la Recherche Agronomique
ITERG
Unilever R&D
Lesieur
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00852735
First received: February 26, 2009
Last updated: March 9, 2010
Last verified: March 2010
  Purpose

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 Intervention
Cardiovascular Diseases
Dietary Supplement: Rapeseed Oil (prevention of cardiovascular diseases)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of the Antioxidant Micronutrients of Rapeseed Oil on the Prevention of Cardiovascular Diseases

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • HDL-Cholestérol [ Time Frame: study 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Rapeseed Oil (prevention of cardiovascular diseases)
    to assess the effect of optimized oil (enriched with micronutriments) on the prevention on cardiovascular diseases
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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852735

Locations
France
CRNH Auvergne
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de la Recherche Agronomique
ITERG
Unilever R&D
Lesieur
Investigators
Principal Investigator: Noël Cano Centre de Recherche en Nutrition Humaine d'Auvergne
  More Information

No publications provided

Responsible Party: Noël CANO, CRNH Auvergne
ClinicalTrials.gov Identifier: NCT00852735     History of Changes
Other Study ID Numbers: CHU-0047, AU 759
Study First Received: February 26, 2009
Last Updated: March 9, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Cardiovascular diseases
Rapeseed oil
Micronutriments
HDL cholesterol
Oxidative stress
Tocopherols
Sterols
Prevention of cardiovascular diseases

Additional relevant MeSH terms:
Cardiovascular Diseases
Antioxidants
Micronutrients
Trace Elements
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances

ClinicalTrials.gov processed this record on July 31, 2014