Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects. (POMEkinetics)
April 13, 2015 updated by: Juan Carlos Espín de Gea, National Research Council, Spain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Murcia, Spain, 30107
- UCAM (San Antonio Catholic University from Murcia)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 31 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-35 years.
- Healthy status (no illness in the previous 3-months).
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pomegranate extract
The same group will consume the two types of pomegranate extract (crossover study).
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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).
Other Names:
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Determination of pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) for ellagic acid and derived metabolites.
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Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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72-h accumulation of urolithins in urine
Time Frame: Changes from baseline at 24, 48 and 72 hours
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Production of urolithins depending on the punicalagin:free ellagic acid ratio.
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Changes from baseline at 24, 48 and 72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Juan Carlos Espín, PhD, National Research Council (CEBAS-CSIC, Murcia, Spain)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
February 4, 2014
First Submitted That Met QC Criteria
February 4, 2014
First Posted (Estimate)
February 6, 2014
Study Record Updates
Last Update Posted (Estimate)
April 14, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- CEBAS-CSIC-3
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