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

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ClinicalTrials.gov Identifier: NCT02293486
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Collaborator:
Vitalgrana Pomegranate SL
Information provided by (Responsible Party):
Néstor Vicente-Salar, Universidad Miguel Hernandez de Elche

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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Dietary Supplement: Pomegranate juice Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Arm Intervention/treatment
No Intervention: Control
Arm that followed all the protocols with the exception of the pomegranate juice intake.
Experimental: Pomegranate Juice
Arm that followed all the protocols and the pomegranate juice intake.
Dietary Supplement: Pomegranate juice
Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.
Other Name: Zumo de Granada Vitalgrana

Experimental: Pomegranate Juice Dilution
Arm that followed all the protocols and the pomegranate juice dilution (1:1) intake.
Dietary Supplement: Pomegranate juice
Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.
Other Name: Zumo de Granada Vitalgrana




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Blood biochemical parameters changes in plasma [ Time Frame: day 0 and 22 ]
    Blood biochemical parameters is a composite outcome measure consisting in circulating plasma glucose (mg·dL-1), HDL-cholesterol (mg·dL-1), triglycerides (mg·dL-1), ferritin (ng·mL-1), lactate (mg·dL-1), sodium (mEq·L-1), potassium (mEq·L-1), creatine kinase (U·L-1), aspartate aminotransferase (U·L-1) and alanine aminotransferase (U·L-1) were analyzed through biochemistry methods.

  2. C-reactive protein levels changes in plasma [ Time Frame: day 0 and 22 ]
    Determination by immunoassay of C-reactive protein (ng·mL-1) levels in plasma.

  3. Soluble E-selectin levels changes in plasma [ Time Frame: day 0 and 22 ]
    Determination by immunoassay of soluble E-selectin (ng·mL-1) levels in plasma.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293486


Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Vitalgrana Pomegranate SL
Investigators
Study Director: Enrique Roche, PhD University Miguel Hernández

Publications of Results:
Responsible Party: Néstor Vicente-Salar, PhD, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT02293486     History of Changes
Other Study ID Numbers: GRA 01
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Néstor Vicente-Salar, Universidad Miguel Hernandez de Elche:
Antioxidants
Protein Carbonylation
Malondialdehyde
Punicaceae
Athletic Performance