Polyphenol Absorption in Healthy PeoplePhase 1/2VOHF1NCT01347515
Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds (VOHF1)
A Phase 1/2 study testing olive oil in people with Polyphenol Absorption in Healthy People, run by University Rovira i Virgili at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyphenol Absorption in Healthy People
- What is being tested?
- olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers aged 20 to 70 years
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Sant Joan, Universitat Rovira i Virgili
Reus, Tarragona, Catalunya
Rosa Solà, MD, PhD, 34 609 906 991, rosa.sola@urv.cat
Montse Giralt, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- olive oil
- Keywords
- Phenol-enriched olive oil, bioavailability, bioactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oilOther
Also called Functional 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.
| Study group | Role | What they receive |
|---|---|---|
| FOO250 | Placebo comparator | FOO250 ppm, the standard virgin olive oil Receives: Other: olive oil |
| FOO500 | Active comparator | Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm Receives: Other: olive oil |
| FOO750 | Active comparator | Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm Receives: Other: olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyphenol Absorption in Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, Universitat de Lleida, Fundacion IMIM
- Investigators
- Rosa Solà, MD, PhD, Principal investigator, Universitat Rovira i Virgili, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347515
- Sponsor's protocol ID
- URoviraiVirgili
- Acronym
- VOHF1
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 30 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds in a Dose-response Study (VOHF1)
- ClinicalTrials.gov ID
- NCT01347515
- Acronym / sponsor ID
- VOHF1 / URoviraiVirgili
- Conditions
- Polyphenol Absorption in Healthy People
- Keywords
- Phenol-enriched olive oil, bioavailability, bioactivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain, Universitat de Lleida, Fundacion IMIM
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOO250 | Placebo comparator | Other: olive oilFOO250 ppm, the standard virgin olive oil |
| FOO500 | Active comparator | Other: olive oilOlive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm |
| FOO750 | Active comparator | Other: olive oilOlive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers aged 20 to 70 years
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olive oilAlso: Functional olive oilEach 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 | FOO250, FOO500, FOO750 |
Primary outcome
Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds
Time frame: Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake
Bioavailability of phenolic compounds from olive oils in plasma and urine until 8h post olive oil-intake.
2 secondary outcomes
Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds
Time frame: Changes form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil
Changes in bioactivity of FOO250, FOO500 and FOO750
Time frame: Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital Universitari Sant Joan, Universitat Rovira i Virgili
Reus, Spain
Rosa Solà, MD, PhD principal investigator
Universitat Rovira i Virgili, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing olive oil in people with Polyphenol Absorption in Healthy People, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds (time frame: Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2011.