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

Polyphenol Absorption in Healthy People Clinical Trial

— VOHF1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01347515
• Other study ID #: URoviraiVirgili
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 26, 2011
• Last updated: May 27, 2011
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2011
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Polyphenol Absorption in Healthy People

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Sant Joan, Universitat Rovira i Virgili	Reus	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
University Rovira i Virgili	Fundacion IMIM, Ministerio de Ciencia e Innovación, Spain, Universitat de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes