NCT02056496

Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects.

Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Gut Microbiota-derived Metabolites (Urolithins) in Overweight Subjects. Comparison Between Two Pomegranate Extracts

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Research Council, Spain · Other Government
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
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).
DIETARY_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).

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2014-02-06
• Last updated: 2015-04-14

Locations

1 site across 1 country: Spain