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

Oxidative Stress Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293486
• Other study ID #: GRA 01
• Status: Completed
• Phase: Phase 0
• First received: November 10, 2014
• Last updated: November 13, 2014
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2014
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• Pomegranate juice
Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Vitalgrana Pomegranate SL

References & 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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	C-reactive protein levels changes in plasma	Determination by immunoassay of C-reactive protein (ng·mL-1) levels in plasma.	day 0 and 22	Yes
Secondary	Soluble E-selectin levels changes in plasma	Determination by immunoassay of soluble E-selectin (ng·mL-1) levels in plasma.	day 0 and 22	Yes