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Completed

NCT Number: NCT05722600

Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers

In the present study, the authors aimed to investigate the effects of hardaliye (grape juice) consumption on oxidative stress parameters, lipid profile and blood pressure in young football players.

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Key information

Conditions

Diet, Healthy Antioxidative Stress

Age range

15 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being a male football player playing in a team in the Elite Development League,
  • Participating in training with the team at least 5 days a week for 3 months,
  • Not consuming red wine, grape juice, and/or hardaliye regularly before the study was started,
  • Those who stayed in the sports facility where catering service was provided for breakfast, lunch and dinner were included in the study.

Exclusion criteria

  • With chronic disease,
  • Smoker,
  • Those taking antioxidant supplements,
  • Non-cooperative subjects or unwilling to sign an informed consent and participate in the study.

Treatment and study plan

Grape juice

Other

Hardaliye (grape juice) is a fermented, traditional non-alcoholic beverage made from fresh grapes. It is mainly produced by the fermentation of grapes, sour cherry leaves and mustard seeds. Hardaliye was purchased from traditional producers in Turkey. Hardaliye Group consumed 250 ml/day of hardaliye (grape juice) for 28 days.

Placebo drink

Other

Placebo drink has carbohydrate, energy and sensory properties similar to hardaliye. Placebo Group consumed 250 ml/day of placebo drink

Primary outcomes

  1. Change in total antioxidant capacity

    Time frame: 28 days

    Measurement of serum level of total antioxidant capacity (μmol Trolox eq/L).

  2. Change in total oxidation status

    Time frame: 28 days

    Measurement of serum level of total oxidation status (μmol H2O2 eq/L).

  3. Change in oxidative stress index

    Time frame: 28 days

    (Serum level of total oxidation status/serum level of total antioxidant capacity) × 100

  4. Change in lipid parameters

    Time frame: 28 days

    Measurement of serum levels total cholesterol (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) and triglycerides (mg/dl).

  5. Change in blood pressure

    Time frame: 28 days

    Measurement of systolic (mm Hg) and diastolic blood pressure (mm Hg)

Secondary outcomes

  1. Change in perceived exercise-induced pain

    Time frame: 28 days

    Perceived exercise-induced pain was determined using the 100-mm Visual Analog Scale. 100-mm Visual Analog Scale scores range from 0 (no pain) to 100 (most severe pain). A higher score indicates a higher perceived pain level.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers: A Randomised Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2023
Registry last updated
Feb 10, 2023

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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