- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837317
Different Oils For Frying and Endothelial Function
May 12, 2009 updated by: Hospital Universitario Reina Sofia de Cordoba
Comparative Effect Of Different Oils For Frying On The Endothelial Function, The Oxidative Stress And The Postprandial Inflammatory Response
The purpose of this study is to compare the effects of the consumption of different oils (olive oil, sunflower oil, sunflower plus dimethyl-polysiloxane, sunflower plus phenols) previously submitted to heating in postprandial endothelial function, inflammation and oxidative stress in healthy young men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To determine whether the consumption by healthy persons of an oil exposed to high temperatures, designed to have a composition of healthy fats (predominantly monounsaturated fats and with less than 10% palmitic acid) and to contain an abundance of antioxidants typically found in olive oil (phenolic compounds), will improve the vasodilatory response that depends on the endothelium, and buffer the inflammatory and postprandial oxidative response that is produced by the oils that are being used ever more frequently for frying purposes (sunflower oil and oil to which butylated hydroxytoluene (BHT) has been added), using virgin olive oil exposed to the same heating regime as a reference oil.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Cordoba, Spain, 14004
- Reina Sofia University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Investigators will select obese people (BMI ranged 25 to 40).
Exclusion Criteria:
- Evidence of malignancy or severally ill (life expectancy lesser than 5 years).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
All the volunteer subjects will be administered four breakfast meals that have been prepared with four different types of oil, each of which will have been subjected to a standardised frying.
The meals will be administered according to a cross-randomized Latin squares design
|
All the volunteer subjects will be administered four breakfast meals that have been prepared with four different types of oil, each of which will have been subjected to a standardised frying.
The meals will be administered according to a cross-randomized Latin squares design
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endothelium-dependent postprandial vasodilatation measured by laser-doppler after the consumption of 4 different oils: -Virgin Olive Oil -Sunflower Oil -Sunflower High Oleic plus phenols -Sunflower High Oleic plus dimethylpolysiloxane
Time Frame: 0, 2, 4 hours after the meals
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0, 2, 4 hours after the meals
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of pro-oxidative state, as evaluated via the determination of F2 isoprostane, nitrates and nitrites, total plasma antioxidative capacity, lipoperoxides and oxidised proteins.
Time Frame: 0 and 4 hours after the meal
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0 and 4 hours after the meal
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Assessment of proinflammatory state in both soluble plasma markers (IL-6, TNF-alpha, MCP-1, VCAM-1, ICAM-1) and the postprandial activation (RNAm) of IL-6, TNF-alpha, Rel-A, I-kappaB-alpha, MIF, MMP-9 y MCP-1 genes.
Time Frame: 0 and 4 hours after the meal
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0 and 4 hours after the meal
|
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Assessment of interrelationship of postprandial lipaemic response and the response of the inflammatory markers and of the oxidative metabolism with each of the oils employed in the study.
Time Frame: 0, 4 hours after the meal
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0, 4 hours after the meal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Francisco Perez-Jimenez, MD, PhD, Reina Sofia University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Estimate)
May 13, 2009
Last Update Submitted That Met QC Criteria
May 12, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oils&Frying
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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