NCT00837317

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 13, 2009

Status Verified

May 1, 2009

Enrollment Period

4 months

First QC Date

February 4, 2009

Last Update Submit

May 12, 2009

Conditions

Endothelial Dysfunction

Keywords

PhenolsLaser-DopplerOlive OilSunflower OilDimethylpolysiloxanePostprandialInflammationOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • 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

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.

    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.

    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.

    0, 4 hours after the meal

Study Arms (1)

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

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

Interventions

Olive Oil, SF, SF+DMP, SF+phenolsDIETARY_SUPPLEMENT

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

Also known as: SF=Sunflower Oil, DMP=dimethylpolysiloxane
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Investigators will select obese people (BMI ranged 25 to 40).

You may not qualify if:

  • Evidence of malignancy or severally ill (life expectancy lesser than 5 years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reina Sofia University Hospital

Córdoba, Cordoba, 14004, Spain

Location

Related Publications (1)

  • 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.

    PMID: 22162245DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Francisco Perez-Jimenez, MD, PhD

    Reina Sofia University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 13, 2009

Record last verified: 2009-05

Locations

ES(1)