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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by University Rovira i Virgili.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Ministerio de Ciencia e Innovación, Spain

Universitat de LLeida, Spain

Fundacion IMIM

Information provided by:

University Rovira i Virgili

ClinicalTrials.gov Identifier:

NCT01347515

First received: April 26, 2011

Last updated: May 27, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 26, 2011

Last Updated Date

May 27, 2011

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds [ Time Frame: Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake ] [ Designated as safety issue: Yes ]

Bioavailability of phenolic compounds from olive oils in plasma and urine until 8h post olive oil-intake.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01347515 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds [ Time Frame: Changes form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil ] [ Designated as safety issue: No ]
Endothelial function will be measured through the assessment of ischemic reactive hyperemia (IRH), at baseline and at 2h, 4 h and 6 after olive oil intake
Changes in bioactivity of FOO250, FOO500 and FOO750 [ Time Frame: Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity ] [ Designated as safety issue: Yes ]
Biomarkers of cardiovascular disease: Oxidative; Lipid profile; Insulin resistance; Inflammation biomarkers; Endothelial dysfunction; Anti-thrombotic activity; Identification and quantification in human plasma and in urine of phenol metabolites

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Bioavailability and Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds in a Dose-response Study (VOHF1)

Brief 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.

Detailed Description

The first step is to determine, in healthy human subjects in postprandial condition, the best relationship between phenolic compounds (amount and type) / bioavailability and bioactivity (antioxidant, anti-inflammatory and anti-endothelial dysfunction) using olive oils enriched with its own broad-spectrum phenolic compounds.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Polyphenol Absorption in Healthy People

Intervention ^ICMJE

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.

Other Name: Functional olive oil

Study Arm (s)

Placebo Comparator: FOO250
FOO250 ppm, the standard virgin olive oil

Intervention: Other: olive oil
Active Comparator: FOO500
Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm

Intervention: Other: olive oil
Active Comparator: FOO750
Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm

Intervention: Other: olive oil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

healthy volunteers aged 20 to 70 years

Exclusion Criteria:

LDL cholesterol levels above 189 mg/dL
Triglycerides ≥350 mg/dL (the upper limit for correctly determining LDL-c by the Friedewald formula)
Physical examination and routine biochemical laboratory determinations will be carried out to exclude co-morbidities
Intake of antioxidant supplement or acetylsalicylic acid or any other drug with known antioxidative properties
Chronic alcoholism
Body mass index (BMI)≥30 kg/m2
Statin treatment prior to initiating the trial; stopped at least 2 months before starting the study
Antihypertensive treatment prior to initiating the trial; stopped at least 2 months before starting the study
Diabetes mellitus (fasting blood glucose > 126 mg/dL; measurements repeated for confirmation)
Renal disease (plasma creatinine levels > 1.4 mg/dL for women and > 1.5 mg/dL for men
Acute infectious diseases, malignancies, severe liver insufficiency, chronic respiratory insufficiency or associated endocrine diseases
Other conditions with special nutritional requirements
Having participated in a clinical trial in the last 3 months, or currently participating in a clinical trial
Inability to continue in the study
History of gastrointestinal disease that can impair the absorption of nutrients
Depression syndrome or self-injuring ideation
High plasma C-reactive protein and ESR concentrations
Immunization in the last 2 months
Anemia

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01347515

Other Study ID Numbers ^ICMJE

URoviraiVirgili

Has Data Monitoring Committee

Yes

Responsible Party

Rosa SOLÀ, URoviraiVirgili

Study Sponsor ^ICMJE

University Rovira i Virgili

Collaborators ^ICMJE

Ministerio de Ciencia e Innovación, Spain
Universitat de LLeida, Spain
Fundacion IMIM

Investigators ^ICMJE

Principal Investigator:

Rosa Solà, MD, PhD

Universitat Rovira i Virgili, Spain

Information Provided By

University Rovira i Virgili

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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