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

Higher Council for Scientific Research (CSIC)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Pomegranate extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02056496

CEBAS-CSIC-3

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Pomegranate extract

Experimental group

Description:

The same group will consume the two types of pomegranate extract (crossover study).

Treatment:

Dietary Supplement: Pomegranate extract

Dietary Supplement: Pomegranate extract