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

Sponsor

Medipol University (Other)

Overall Status

Completed

CT.gov ID

NCT05722600

Collaborator

(none)

Enrollment

Location

Arms

1.1

Actual Duration (Months)

31.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy Antioxidative Stress	Other: Grape juice Other: Placebo drink	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Mar 8, 2022

Actual Study Completion Date :

Mar 8, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in total antioxidant capacity [28 days]
Measurement of serum level of total antioxidant capacity (μmol Trolox eq/L).
Change in total oxidation status [28 days]
Measurement of serum level of total oxidation status (μmol H2O2 eq/L).
Change in oxidative stress index [28 days]
(Serum level of total oxidation status/serum level of total antioxidant capacity) × 100
Change in lipid parameters [28 days]
Measurement of serum levels total cholesterol (mg/dl), HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl) and triglycerides (mg/dl).
Change in blood pressure [28 days]
Measurement of systolic (mm Hg) and diastolic blood pressure (mm Hg)

Secondary Outcome Measures

Change in perceived exercise-induced pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University	İstanbul		Turkey

Sponsors and Collaborators

Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramazan Mert Atan, Principal Investigator, Medipol University

ClinicalTrials.gov Identifier:

NCT05722600

Other Study ID Numbers:

RMAtan

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 10, 2023