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

NCT ID: NCT01347515

Last Updated: 2011-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-09-30

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.

Conditions

Polyphenol Absorption in Healthy People

Keywords

Phenol-enriched olive oil; bioavailability; bioactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

FOO250

FOO250 ppm, the standard virgin olive oil

Group Type: PLACEBO_COMPARATOR

olive oil

Intervention Type: OTHER

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.

FOO500

Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm

Group Type: ACTIVE_COMPARATOR

olive oil

Intervention Type: OTHER

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.

FOO750

Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm

Group Type: ACTIVE_COMPARATOR

olive oil

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Functional olive oil

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role: collaborator

Universitat de Lleida

OTHER

Sponsor Role: collaborator

Fundacion IMIM

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: lead

Responsible Party

URoviraiVirgili

Principal Investigators

Rosa Solà, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Rovira i Virgili, Spain

Locations

Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Reus, Tarragona, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Rosa Solà, MD, PhD

Role: primary

Other Identifiers

URoviraiVirgili

Identifier Type: -

Identifier Source: org_study_id