HealthyPhase 1POMEkineticsNCT02056496
Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects.
A Phase 1 study testing Pomegranate extract in people with Healthy, run by National Research Council, Spain at 1 site in Spain.
Trial summary
Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pomegranate extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Feb 2014
- Phase
- Phase 1
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years.
- Healthy status (no illness in the previous 3-months).
Who cannot join
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
- Suspected hypersensitivity to pomegranate or any of its components
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- Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
Trial locations and contacts
1 site in 1 country.
Spain1 site
UCAM (San Antonio Catholic University from Murcia)
Murcia, Murcia, 30107
About this study
Official title: Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Gut Microbiota-derived Metabolites (Urolithins) in Overweight Subjects. Comparison Between Two Pomegranate Extracts
Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities. However, the bioavailability of ellagic acid has been reported to be very low and the existing studies are controversial so far. The investigators want to carry out a robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be administered. The investigators will analyze blood and urine samples using UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:
- The pharmacokinetics of EA.
- The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins production.
- Conditions
- Healthy
- Being tested
- Pomegranate extract
- Keywords
- Pomegranate, Ellagic acid, Pharmacokinetics, Urolithins, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate extractDietary supplement
Also called PE-1
Crossover study: The group will consume the pomegranate extract with low punicalagin:EA ratio (PE-1). After 2 weeks of washout, the same group will also consume the other extract with high punicalagin: EA ratio (PE-2).
Pomegranate extractDietary supplement
Also called PE-2
Crossover study: The group will consume the pomegranate extract with high punicalagin:EA ratio (PE-2) after 2 weeks of washout. The same group will also consume the other extract with low punicalagin: EA ratio (PE-1).
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate extract | Experimental | The same group will consume the two types of pomegranate extract (crossover study). Receives: Dietary Supplement: Pomegranate extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour pharmacokinetics of ellagic acid in plasma
Determination of pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) for ellagic acid and derived metabolites.
Measured: Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.
Secondary outcomes (1)
72-h accumulation of urolithins in urine
Production of urolithins depending on the punicalagin:free ellagic acid ratio.
Measured: Changes from baseline at 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Universidad Católica San Antonio de Murcia
- Responsible party
- Principal investigator, Juan Carlos Espín de Gea, National Research Council, Spain
- Investigators
- Dr. Juan Carlos Espín, PhD, Principal investigator, National Research Council (CEBAS-CSIC, Murcia, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056496
- Sponsor's protocol ID
- CEBAS-CSIC-3
- Acronym
- POMEkinetics
- Status last verified
- Apr 2015
- First submitted
- 4 Feb 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Gut Microbiota-derived Metabolites (Urolithins) in Overweight Subjects. Comparison Between Two Pomegranate Extracts
- ClinicalTrials.gov ID
- NCT02056496
- Acronym / sponsor ID
- POMEkinetics / CEBAS-CSIC-3
- Conditions
- Healthy
- Keywords
- Pomegranate, Ellagic acid, Pharmacokinetics, Urolithins, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Universidad Católica San Antonio de Murcia
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Feb 2014 (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.
Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities. However, the bioavailability of ellagic acid has been reported to be very low and the existing studies are controversial so far. The investigators want to carry out a robust (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be administered. The investigators will analyze blood and urine samples using UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:
- The pharmacokinetics of EA.
- The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins production.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomegranate extract | Experimental | Dietary Supplement: Pomegranate extractThe same group will consume the two types of pomegranate extract (crossover study). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-35 years.
- Healthy status (no illness in the previous 3-months).
Key exclusion criteria (9 listed)
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
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 |
|---|---|---|
| Pomegranate extractAlso: PE-1Crossover study: The group will consume the pomegranate extract with low punicalagin:EA ratio (PE-1). After 2 weeks of washout, the same group will also consume the other extract with high punicalagin: EA ratio (PE-2). | Dietary supplement | Pomegranate extract |
| Pomegranate extractAlso: PE-2Crossover study: The group will consume the pomegranate extract with high punicalagin:EA ratio (PE-2) after 2 weeks of washout. The same group will also consume the other extract with low punicalagin: EA ratio (PE-1). | Dietary supplement | Pomegranate extract |
Primary outcome
24-hour pharmacokinetics of ellagic acid in plasma
Time frame: Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.
Determination of pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) for ellagic acid and derived metabolites.
1 secondary outcome
72-h accumulation of urolithins in urine
Time frame: Changes from baseline at 24, 48 and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
Dr. Juan Carlos Espín, PhD principal investigator
National Research Council (CEBAS-CSIC, Murcia, 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 study testing Pomegranate extract in people with Healthy, run by National Research Council, Spain 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 14 Apr 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour pharmacokinetics of ellagic acid in plasma (time frame: Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.). 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 14 Apr 2015.