NCT02056496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

Same day

First QC Date

February 4, 2014

Last Update Submit

April 13, 2015

Conditions

Healthy

Keywords

PomegranateEllagic acidPharmacokineticsUrolithinsBioavailability

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 72-h accumulation of urolithins in urine

    Changes from baseline at 24, 48 and 72 hours

Study Arms (1)

Pomegranate extract

EXPERIMENTAL

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

Dietary Supplement: Pomegranate extract

Interventions

Pomegranate extractDIETARY_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).

Also known as: PE-1
Pomegranate extract

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-35 years.
  • Healthy status (no illness in the previous 3-months).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM (San Antonio Catholic University from Murcia)

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Interventions

pomegranate fruit rind

Study Officials

  • Dr. Juan Carlos Espín, PhD

    National Research Council (CEBAS-CSIC, Murcia, Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Research Professor

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 6, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

ES(1)