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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02056496

Acronym

POMEkinetics

Enrollment

Registered

2014-02-06

Start date

2014-01-31

Completion date

2014-02-28

Last updated

2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pomegranate, Ellagic acid, Pharmacokinetics, Urolithins, Bioavailability

Brief 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.

Interventions

DIETARY_SUPPLEMENTPomegranate 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).

Study design

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
24-hour pharmacokinetics of ellagic acid in plasma	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.

Secondary

Measure	Time frame	Description
72-h accumulation of urolithins in urine	Changes from baseline at 24, 48 and 72 hours	Production of urolithins depending on the punicalagin:free ellagic acid ratio.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026