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

NCT05722600 | Completed

• 1 other identifier: RMAtan
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet, Healthy; Antioxidative Stress

Outcome Measures

Primary Outcomes (5)

• Change in total antioxidant capacity

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

  28 days

• Change in total oxidation status

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

  28 days

• Change in oxidative stress index

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

  28 days

• Change in lipid parameters

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

  28 days

• Change in blood pressure

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

  28 days

Secondary Outcomes (1)

• Change in perceived exercise-induced pain

  28 days

Study Arms (2)

Hardaliye Group

EXPERIMENTAL

Hardaliye Group consumed 250 ml/day of hardaliye (grape juice) for 28 days.

Other: Grape juice

Placebo Group

PLACEBO COMPARATOR

Placebo Group consumed 250 ml/day of placebo drink for 28 days.

Other: Placebo drink

Interventions

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.

Hardaliye Group

Placebo drink OTHER

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

Placebo Group

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 10, 2023
• Study Start: February 1, 2022
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)