Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects. (POMEkinetics)
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|ClinicalTrials.gov Identifier: NCT02056496|
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : April 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Pomegranate extract||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Basic Science|
|Official Title:||Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Gut Microbiota-derived Metabolites (Urolithins) in Overweight Subjects. Comparison Between Two Pomegranate Extracts|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Pomegranate extract
The same group will consume the two types of pomegranate extract (crossover study).
Dietary Supplement: Pomegranate extract
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 Name: PE-1Dietary Supplement: Pomegranate extract
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 Name: PE-2
- 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.
- 72-h accumulation of urolithins in urine [ Time Frame: Changes from baseline at 24, 48 and 72 hours ]Production of urolithins depending on the punicalagin:free ellagic acid ratio.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056496
|UCAM (San Antonio Catholic University from Murcia)|
|Murcia, Spain, 30107|
|Principal Investigator:||Dr. Juan Carlos Espín, PhD||National Research Council (CEBAS-CSIC, Murcia, Spain)|