Diet, HealthyNCT05722600
Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers
A study testing Grape juice in people with Diet, Healthy and Antioxidative Stress, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Antioxidative Stress
- What is being tested?
- Grape juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 8 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- With chronic disease,
- Smoker,
- Those taking antioxidant supplements,
- Non-cooperative subjects or unwilling to sign an informed consent and participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diet, Healthy, Antioxidative Stress
- Being tested
- Grape juice, Placebo drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape juiceOther
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 drinkOther
Placebo drink has carbohydrate, energy and sensory properties similar to hardaliye. Placebo Group consumed 250 ml/day of placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Hardaliye Group | Experimental | Hardaliye Group consumed 250 ml/day of hardaliye (grape juice) for 28 days. Receives: Other: Grape juice |
| Placebo Group | Placebo comparator | Placebo Group consumed 250 ml/day of placebo drink for 28 days. Receives: Other: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total antioxidant capacity
Measurement of serum level of total antioxidant capacity (μmol Trolox eq/L).
Measured: 28 days
Change in total oxidation status
Measurement of serum level of total oxidation status (μmol H2O2 eq/L).
Measured: 28 days
Change in oxidative stress index
(Serum level of total oxidation status/serum level of total antioxidant capacity) × 100
Measured: 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).
Measured: 28 days
Change in blood pressure
Measurement of systolic (mm Hg) and diastolic blood pressure (mm Hg)
Measured: 28 days
Secondary outcomes (1)
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Feb 2022
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Mert Atan, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722600
- Sponsor's protocol ID
- RMAtan
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hardaliye, a Fermented Grape Drink, on Oxidative Stress, Lipid Profile and Blood Pressure in Young Footballers: A Randomised Trial
- ClinicalTrials.gov ID
- NCT05722600
- Acronym / sponsor ID
- RMAtan
- Conditions
- Diet, Healthy, Antioxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hardaliye Group | Experimental | Other: Grape juiceHardaliye Group consumed 250 ml/day of hardaliye (grape juice) for 28 days. |
| Placebo Group | Placebo comparator | Other: Placebo drinkPlacebo Group consumed 250 ml/day of placebo drink for 28 days. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- With chronic disease,
- Smoker,
- Those taking antioxidant supplements,
- Non-cooperative subjects or unwilling to sign an informed consent and participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape juiceHardaliye (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. | Other | Hardaliye Group |
| Placebo drinkPlacebo drink has carbohydrate, energy and sensory properties similar to hardaliye. Placebo Group consumed 250 ml/day of placebo drink | Other | Placebo Group |
Primary outcome
Change in total antioxidant capacity
Time frame: 28 days
Measurement of serum level of total antioxidant capacity (μmol Trolox eq/L).
Change in total oxidation status
Time frame: 28 days
Measurement of serum level of total oxidation status (μmol H2O2 eq/L).
Change in oxidative stress index
Time frame: 28 days
(Serum level of total oxidation status/serum level of total antioxidant capacity) × 100
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).
Change in blood pressure
Time frame: 28 days
Measurement of systolic (mm Hg) and diastolic blood pressure (mm Hg)
1 secondary outcome
Change in perceived exercise-induced pain
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape juice in people with Diet, Healthy and Antioxidative Stress, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total antioxidant capacity (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.