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

NCT01347515 | Unknown Phase 1 DMC

• 1 other identifier: URoviraiVirgili
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Polyphenol Absorption in Healthy People

Keywords

Phenol-enriched olive oil; bioavailability; bioactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds

  Changes form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil

• Changes in bioactivity of FOO250, FOO500 and FOO750

  Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity

Study Arms (3)

FOO250

PLACEBO COMPARATOR

FOO250 ppm, the standard virgin olive oil

Other: olive oil

FOO500

ACTIVE COMPARATOR

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

Other: olive oil

FOO750

ACTIVE COMPARATOR

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

Other: olive oil

Interventions

olive oil 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.

Also known as: Functional olive oil

FOO250; FOO500; FOO750

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers aged 20 to 70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator
• Universitat de Lleida: collaborator
• Fundacion IMIM: collaborator

Study Sites (1)

Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Reus, Tarragona, Catalunya, Spain

RECRUITING

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Rosa Solà, MD, PhD

  Universitat Rovira i Virgili, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: May 4, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 30, 2011

Record last verified: 2011-04

Locations

ES (1)