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Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds (VOHF1)

NCT01347515 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-05-30

No results posted yet for this study

Summary

Hypothesis: A functional olive oil tailored to provide the best relationship between phenolic compounds (amount and type) phenolic bioavailability and bioactivity (antioxidant and anti-endothelial dysfunction) will be a useful tool for increasing not only circulating HDL cholesterol concentration, but also the functionality (antioxidant, anti-inflammatory, and reverse cholesterol transport capacity) of human HDL in vivo.

Conditions

  • Polyphenol Absorption in Healthy People

Interventions

OTHER

olive oil

Each volunteer will be given, in random order, a single dose of 30 ml on a base of 80 g bread, of the following functional olive oils (FOO): FOO750 ppm, FOO500 ppm, which are enriched with two different amounts of broad-spectrum phenolic compounds from the virgin FOO250 ppm; all prepared at the Universitat de Lleida. Post-ingestion the volunteers will rest for 8h in a comfortable warm room. During the run-in period of 2 weeks prior the first postprandial study and 1 week between each FOO treatment period, all subjects will undergo a 2-day pre-treatment wash-out period of a phenol-free diet (saturated fatty acids in the diet will be 10-13% of energy in an isocaloric diet). Volunteers will avoid non-essential physical activity during the 3 days prior to the treatment day.

Sponsors & Collaborators

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Universitat de Lleida

    collaborator OTHER

  • Fundacion IMIM

    collaborator OTHER

  • University Rovira i Virgili

    lead OTHER

Principal Investigators

  • Rosa Solà, MD, PhD · Universitat Rovira i Virgili, Spain

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347515 on ClinicalTrials.gov