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

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

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.

Study Overview

• Status: Completed
• Conditions: Diet, Healthy; Antioxidative Stress
• Intervention / Treatment: Other: Grape juice; Other: Placebo drink

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hardaliye Group; Hardaliye Group consumed 250 ml/day of hardaliye (grape juice) for 28 days.	Other: Grape juice; 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_COMPARATOR: Placebo Group; Placebo Group consumed 250 ml/day of placebo drink for 28 days.	Other: Placebo drink; Placebo drink has carbohydrate, energy and sensory properties similar to hardaliye. Placebo Group consumed 250 ml/day of placebo drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived exercise-induced pain	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.	28 days

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ACTUAL): March 8, 2022
• Study Completion (ACTUAL): March 8, 2022

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RMAtan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No