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Clinical Trials/NCT02293486
NCT02293486CompletedPhase 1

Study of Pomegranate Juice in the Modulation of Oxidative Stress Markers in Endurance-based Athletes

Universidad Miguel Hernandez de Elche0 sites20 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Primary Endpoint
Protein carbonyls levels changes in plasma

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Pomegranate juice (Dietary Supplement)

Pomegranate Juice Dilution

Experimental

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

Intervention: Pomegranate juice (Dietary Supplement)

Outcomes

Primary Outcomes

Protein carbonyls levels changes in plasma

Time Frame: day 0 and 22

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

Malondialdehyde levels changes in plasma

Time Frame: day 0 and 22

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Néstor Vicente-Salar

PhD

Universidad Miguel Hernandez de Elche

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