Trial | NCT01347515  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    12
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.
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 Started
Apr 30
2011
Primary Completion
Jun 30
2011
Anticipated
Study Completion
Sep 30
2011
Anticipated
Last Update
May 30
2011
Estimate

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

FOO250 Placebo Comparator

FOO250 ppm, the standard virgin olive oil

FOO500 Active Comparator

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

FOO750 Active Comparator

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

Criteria 

Inclusion Criteria:

healthy volunteers aged 20 to 70 years

Exclusion Criteria:

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
Depression syndrome or self-injuring ideation
High plasma C-reactive protein and ESR concentrations
Immunization in the last 2 months
Anemia
No Results Posted