Trial record 4 of 54 for:    pomegranate

Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects. (POMEkinetics)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
San Antonio Catholic University of Murcia
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT02056496
First received: February 4, 2014
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Healthy
Dietary Supplement: Pomegranate extract
Phase 1

Study Type: Interventional
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

Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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-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 Name: PE-2

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02056496

Locations
Spain
UCAM (San Antonio Catholic University from Murcia)
Murcia, Spain, 30107
Sponsors and Collaborators
National Research Council, Spain
San Antonio Catholic University of Murcia
Investigators
Principal Investigator: Dr. Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
  More Information

No publications provided

Responsible Party: Juan Carlos Espín de Gea, Full Research Professor, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT02056496     History of Changes
Other Study ID Numbers: CEBAS-CSIC-3
Study First Received: February 4, 2014
Last Updated: February 6, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by National Research Council, Spain:
Pomegranate
Ellagic acid
Pharmacokinetics
Urolithins
Bioavailability

ClinicalTrials.gov processed this record on April 22, 2014