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

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 Overview

• Status: Completed
• Conditions: Oxidative Stress
• Intervention / Treatment: Dietary supplement: Pomegranate juice

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Zumo de Granada Vitalgrana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood biochemical parameters changes in plasma	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.	day 0 and 22
C-reactive protein levels changes in plasma	Determination by immunoassay of C-reactive protein (ng·mL-1) levels in plasma.	day 0 and 22
Soluble E-selectin levels changes in plasma	Determination by immunoassay of soluble E-selectin (ng·mL-1) levels in plasma.	day 0 and 22

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Vitalgrana Pomegranate SL
• Investigators: Study Director: Enrique Roche, PhD, University Miguel Hernandez

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Antioxidants; Malondialdehyde; Punicaceae; Athletic Performance; Protein Carbonylation
• Other Study ID Numbers: GRA 01