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

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

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.

Study Overview

• Status: Unknown
• Conditions: Polyphenol Absorption in Healthy People
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, Catalunya
      • Recruiting
      • Hospital Universitari Sant Joan, Universitat Rovira i Virgili
      • Contact: Rosa Solà, MD, PhD; Phone Number: 34 609 906 991; Email: rosa.sola@urv.cat
      • Sub-Investigator: Montse Giralt, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Functional olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds	Bioavailability of phenolic compounds from olive oils in plasma and urine until 8h post olive oil-intake.	Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds	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 form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil
Changes in bioactivity of FOO250, FOO500 and FOO750	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	Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity

Collaborators and Investigators

• Sponsor: University Rovira i Virgili
• Collaborators: Universitat de Lleida; Ministerio de Ciencia e Innovación, Spain; Fundacion IMIM
• Investigators: Principal Investigator: Rosa Solà, MD, PhD, Universitat Rovira i Virgili, Spain

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): June 1, 2011
• Study Completion (ANTICIPATED): September 1, 2011

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: May 3, 2011
• First Posted (ESTIMATE): May 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2011
• Last Update Submitted That Met QC Criteria: May 27, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: bioavailability; Phenol-enriched olive oil; bioactivity
• Other Study ID Numbers: URoviraiVirgili