NCT02293486

Brief Summary

The purpose of this study is to evaluate modifications of plasma protein carbonyls and malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice consumption.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for early_phase_1

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

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

November 10, 2014

Last Update Submit

November 13, 2014

Conditions

Oxidative Stress

Keywords

AntioxidantsProtein CarbonylationMalondialdehydePunicaceaeAthletic Performance

Outcome Measures

Primary Outcomes (2)

  • Protein carbonyls levels changes in plasma

    Protein carbonyl derivatives were determined using an adaptation of the colorimetric method published in Levine et al. (1994) based in the formation of a stable 2,4-dinitrophenyl (DNP) hydrazone product after the addition of 2,4-dinitrophenylhydrazine (DNPH) to tha plasma. Protein carbonyls were calculated as nmoles·mg-1 protein

    day 0 and 22

  • Malondialdehyde levels changes in plasma

    Malondialdehyde was determined by high pressure liquid chromatography (HPLC) with fluorescence detection according to the method described by Laporta et al. (2007). Malondialdehyde levels were calculated as nmoles·g-1 protein

    day 0 and 22

Secondary Outcomes (3)

  • Blood biochemical parameters changes in plasma

    day 0 and 22

  • C-reactive protein levels changes in plasma

    day 0 and 22

  • Soluble E-selectin levels changes in plasma

    day 0 and 22

Study Arms (3)

Control

NO INTERVENTION

Arm that followed all the protocols with the exception of the pomegranate juice intake.

Pomegranate Juice

EXPERIMENTAL

Arm that followed all the protocols and the pomegranate juice intake.

Dietary Supplement: Pomegranate juice

Pomegranate Juice Dilution

EXPERIMENTAL

Arm that followed all the protocols and the pomegranate juice dilution (1:1) intake.

Dietary Supplement: Pomegranate juice

Interventions

Pomegranate juiceDIETARY_SUPPLEMENT

Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.

Also known as: Zumo de Granada Vitalgrana
Pomegranate JuicePomegranate Juice Dilution

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Perform specific endurance training sessions
  • More than 1 hour per session and more than 3 sessions per week
  • Have participated recently in a half marathon or similar event

You may not qualify if:

  • Intake of antioxidant or anti-inflammatory supplementation
  • Present a chronic disorder
  • Non-smoker
  • No-alcoholic beverage consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Aviram M, Dornfeld L, Rosenblat M, Volkova N, Kaplan M, Coleman R, Hayek T, Presser D, Fuhrman B. Pomegranate juice consumption reduces oxidative stress, atherogenic modifications to LDL, and platelet aggregation: studies in humans and in atherosclerotic apolipoprotein E-deficient mice. Am J Clin Nutr. 2000 May;71(5):1062-76. doi: 10.1093/ajcn/71.5.1062.

    PMID: 10799367RESULT

  • Trombold JR, Reinfeld AS, Casler JR, Coyle EF. The effect of pomegranate juice supplementation on strength and soreness after eccentric exercise. J Strength Cond Res. 2011 Jul;25(7):1782-8. doi: 10.1519/JSC.0b013e318220d992.

    PMID: 21659887RESULT

Study Officials

  • Enrique Roche, PhD

    University Miguel Hernández

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 18, 2014

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

November 18, 2014

Record last verified: 2014-11