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Completed

NCT Number: NCT02056496

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

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCAM (San Antonio Catholic University from Murcia)

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pomegranate extract

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Universidad Católica San Antonio de Murcia

Registry information

Official study title

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

Acronym: POMEkinetics

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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