Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects. (POMEkinetics)
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:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
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|
- 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Production of urolithins depending on the punicalagin:free ellagic acid ratio.
|Study Start Date:||January 2014|
|Study Completion Date:||February 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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)|