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Trial record 4 of 82 for:    pomegranate

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

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ClinicalTrials.gov Identifier: NCT02056496
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
Universidad Católica San Antonio de Murcia
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Pomegranate extract Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

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 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056496


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

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
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Juan Carlos Espín de Gea, National Research Council, Spain:
Pomegranate
Ellagic acid
Pharmacokinetics
Urolithins
Bioavailability