Different Oils For Frying and Endothelial Function

Endothelial Dysfunction Clinical Trial

Official title:

Comparative Effect Of Different Oils For Frying On The Endothelial Function, The Oxidative Stress And The Postprandial Inflammatory Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837317
• Other study ID #: Oils&Frying
• Status: Completed
• Phase: N/A
• First received: February 4, 2009
• Last updated: May 12, 2009
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Hospital Universitario Reina Sofia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Dietary Supplement:
• Olive Oil, SF, SF+DMP, SF+phenols
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

Locations

Country	Name	City	State
Spain	Reina Sofia University Hospital	Cordoba

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Reina Sofia	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		0, 2, 4 hours after the meals	No
Secondary	Assessment of pro-oxidative state, as evaluated via the determination of F2 isoprostane, nitrates and nitrites, total plasma antioxidative capacity, lipoperoxides and oxidised proteins.		0 and 4 hours after the meal	No
Secondary	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.		0 and 4 hours after the meal	No
Secondary	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.		0, 4 hours after the meal	No