Endothelial DysfunctionNCT00837317
Different Oils For Frying and Endothelial Function
A study testing Olive Oil, SF, SF+DMP, SF+phenols in people with Endothelial Dysfunction, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Olive Oil, SF, SF+DMP, SF+phenols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Investigators will select obese people (BMI ranged 25 to 40).
Who cannot join
- Evidence of malignancy or severally ill (life expectancy lesser than 5 years).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endothelial Dysfunction
- Being tested
- Olive Oil, SF, SF+DMP, SF+phenols
- Keywords
- Phenols, Laser-Doppler, Olive Oil, Sunflower Oil, Dimethylpolysiloxane, Postprandial, Inflammation, Oxidative Stress
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil, SF, SF+DMP, SF+phenolsDietary supplement
Also called SF=Sunflower Oil, DMP=dimethylpolysiloxane
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Dietary Supplement: Olive Oil, SF, SF+DMP, SF+phenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 2, 4 hours after the meals
Secondary outcomes (3)
Assessment of pro-oxidative state, as evaluated via the determination of F2 isoprostane, nitrates and nitrites, total plasma antioxidative capacity, lipoperoxides and oxidised proteins.
Measured: 0 and 4 hours after the meal
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.
Measured: 0 and 4 hours after the meal
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.
Measured: 0, 4 hours after the meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Investigators
- Francisco Perez-Jimenez, MD, PhD, Principal investigator, Reina Sofia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837317
- Sponsor's protocol ID
- Oils&Frying
- Status last verified
- May 2009
- First submitted
- 4 Feb 2009
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Herrera A, Delgado-Lista J, Torres-Sanchez LA, Rangel-Zuniga OA, Camargo A, Moreno-Navarrete JM, Garcia-Olid B, Quintana-Navarro GM, Alcala-Diaz JF, Munoz-Lopez C, Lopez-Segura F, Fernandez-Real JM, Luque de Castro MD, Lopez-Miranda J, Perez-Jimenez F. The postprandial inflammatory response after ingestion of heated oils in obese persons is reduced by the presence of phenol compounds. Mol Nutr Food Res. 2012 Mar;56(3):510-4. doi: 10.1002/mnfr.201100533. Epub 2011 Dec 9.
PubMed 22162245
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect Of Different Oils For Frying On The Endothelial Function, The Oxidative Stress And The Postprandial Inflammatory Response
- ClinicalTrials.gov ID
- NCT00837317
- Acronym / sponsor ID
- Oils&Frying
- Conditions
- Endothelial Dysfunction
- Keywords
- Phenols, Laser-Doppler, Olive Oil, Sunflower Oil, Dimethylpolysiloxane, Postprandial, Inflammation, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Olive Oil, SF, SF+DMP, SF+phenolsAll 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Investigators will select obese people (BMI ranged 25 to 40).
Key exclusion criteria (1 listed)
- Evidence of malignancy or severally ill (life expectancy lesser than 5 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive Oil, SF, SF+DMP, SF+phenolsAlso: SF=Sunflower Oil, DMP=dimethylpolysiloxaneAll 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 | Dietary supplement | 1 |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2009.
- Derived from this study: PubMed 22162245Perez-Herrera A, Delgado-Lista J, Torres-Sanchez LA, Rangel-Zuniga OA, Camargo A, Moreno-Navarrete JM, Garcia-Olid B, Quintana-Navarro GM, Alcala-Diaz JF, Munoz-Lopez C, Lopez-Segura F, Fernandez-Real JM, Luque de Castro MD, Lopez-Miranda J, Perez-Jimenez F. The postprandial inflammatory response after ingestion of heated oils in obese persons is reduced by the presence of phenol compounds. Mol Nutr Food Res. 2012 Mar;56(3):510-4. doi: 10.1002/mnfr.201100533. Epub 2011 Dec 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Perez-Jimenez, MD, PhD principal investigator
Reina Sofia University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Oil, SF, SF+DMP, SF+phenols in people with Endothelial Dysfunction, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2009.