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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05722600
• Other study ID #: RMAtan
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 8, 2022

Study information

• Verified date: February 2023
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total antioxidant capacity	Measurement of serum level of total antioxidant capacity (µmol Trolox eq/L).	28 days
Primary	Change in total oxidation status	Measurement of serum level of total oxidation status (µmol H2O2 eq/L).	28 days
Primary	Change in oxidative stress index	(Serum level of total oxidation status/serum level of total antioxidant capacity) × 100	28 days
Primary	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
Primary	Change in blood pressure	Measurement of systolic (mm Hg) and diastolic blood pressure (mm Hg)	28 days
Secondary	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