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Completed

NCT Number: NCT02293486

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.

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Key information

Conditions

Oxidative Stress

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pomegranate Juice

Dietary Supplement

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

Other names: Zumo de Granada Vitalgrana

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Vitalgrana Pomegranate SL

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 18, 2014
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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