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
  Purpose

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.


Condition Intervention Phase
Polyphenol Absorption in Healthy People
Other: olive oil
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Bioavailability and Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds in a Dose-response Study (VOHF1)

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: FOO250
FOO250 ppm, the standard virgin olive oil
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
Active Comparator: FOO500
Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm
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
Active Comparator: FOO750
Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers aged 20 to 70 years

Exclusion Criteria:

  1. LDL cholesterol levels above 189 mg/dL
  2. Triglycerides ≥350 mg/dL (the upper limit for correctly determining LDL-c by the Friedewald formula)
  3. Physical examination and routine biochemical laboratory determinations will be carried out to exclude co-morbidities
  4. Intake of antioxidant supplement or acetylsalicylic acid or any other drug with known antioxidative properties
  5. Chronic alcoholism
  6. Body mass index (BMI)≥30 kg/m2
  7. Statin treatment prior to initiating the trial; stopped at least 2 months before starting the study
  8. Antihypertensive treatment prior to initiating the trial; stopped at least 2 months before starting the study
  9. Diabetes mellitus (fasting blood glucose > 126 mg/dL; measurements repeated for confirmation)
  10. Renal disease (plasma creatinine levels > 1.4 mg/dL for women and > 1.5 mg/dL for men
  11. Acute infectious diseases, malignancies, severe liver insufficiency, chronic respiratory insufficiency or associated endocrine diseases
  12. Other conditions with special nutritional requirements
  13. Having participated in a clinical trial in the last 3 months, or currently participating in a clinical trial
  14. Inability to continue in the study
  15. History of gastrointestinal disease that can impair the absorption of nutrients
  16. Depression syndrome or self-injuring ideation
  17. High plasma C-reactive protein and ESR concentrations
  18. Immunization in the last 2 months
  19. Anemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347515

Locations
Spain
Hospital Universitari Sant Joan, Universitat Rovira i Virgili Recruiting
Reus, Tarragona, Spain, Catalunya
Contact: Rosa Solà, MD, PhD    34 609 906 991    rosa.sola@urv.cat   
Sub-Investigator: Montse Giralt, MD, PhD         
Sponsors and Collaborators
University Rovira i Virgili
Ministerio de Ciencia e Innovación, Spain
Universitat de LLeida, Spain
Fundacion IMIM
Investigators
Principal Investigator: Rosa Solà, MD, PhD Universitat Rovira i Virgili, Spain
  More Information

No publications provided

Responsible Party: Rosa SOLÀ, URoviraiVirgili
ClinicalTrials.gov Identifier: NCT01347515     History of Changes
Other Study ID Numbers: URoviraiVirgili
Study First Received: April 26, 2011
Last Updated: May 27, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by University Rovira i Virgili:
Phenol-enriched olive oil
bioavailability
bioactivity

ClinicalTrials.gov processed this record on September 18, 2014