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

  • Spain
      • Murcia, Spain, 30107
        • UCAM (San Antonio Catholic University from Murcia)

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
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 Names:
  • PE-1
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).
Other Names:
  • PE-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measures at 0.5, 1, 2, 3, 4, 5, 6, and 24 hours post-dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Changes from baseline at 24, 48 and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Council, Spain

Collaborators

Universidad Católica San Antonio de Murcia

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

Keywords

Other Study ID Numbers

  • CEBAS-CSIC-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Pomegranate extract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe