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

Healthy Clinical Trial

— POMEkinetics  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056496
• Other study ID #: CEBAS-CSIC-3
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2014
• Last updated: April 13, 2015
• Start date: January 2014
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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).

Locations

Country	Name	City	State
Spain	UCAM (San Antonio Catholic University from Murcia)	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
National Research Council, Spain	Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour pharmacokinetics of ellagic acid in plasma	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.	No
Secondary	72-h accumulation of urolithins in urine	Production of urolithins depending on the punicalagin:free ellagic acid ratio.	Changes from baseline at 24, 48 and 72 hours	No