Handball PlayersNCT04274582
The Influences of Chokeberry Extract Supplementation on Handball Players
A study testing chokeberry extract in people with Handball Players, run by University of Kragujevac at 1 site in Serbia.
Trial summary
The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd". All study participants were apparently healthy, had no active sports injuries, did not use any medications, and were non-smokers. Read more about this study
- Who is it for?
- Ages 16 to 24 years, men only
- Conditions the study is for
- Handball Players
- What is being tested?
- chokeberry extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSerbia
- Study dates
- 4 Mar 2019to 3 Jun 2019
- 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 16 to 24 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- healthy handball players of handball club "Novi Beograd" during competition phase.
Who cannot join
- active sports injuries,
- usage of any medications,
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influences of Chokeberry Extract Supplementation on Redox Status and Body Composition in Handball Players During Competition Phase
The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd". All study participants were apparently healthy, had no active sports injuries, did not use any medications, and were non-smokers. Standardized questionnaires conducted under the supervision of a trained nutritionist were used to collect general data, nutritional habits and use of dietary supplements. The athletes who used any dietary supplements at least a month before the study, were excluded. All participants (or their parents if they were under the age of 18) signed an informed consent document. The study was approved by the Ethical committee of The Military Medical Academy, Belgrade.
The study was conducted during regular competition season, and lasted for twelve weeks. All participants had the same training and nutritional regime, which excluded intake of berries. The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. For the preparation of chokeberry extract (liquid form) was used fruit (berries) of Aronia melanocarpa Elliot, Rosaceae. The extract was donated by Pharmanova Belgrade, Serbia. Process of extraction is performed under specific conditions which are subject of technical patent (producer EUHEM), for the purpose of production of extract with high concentration of polyphenols. The design of the product included few demands: sufficient daily dose of polyphenols to be dietary supplement, small volume which can be consumed as shot and acceptable taste for most consumers. Compliance was monitored by the trainers.
- Conditions
- Handball Players
- Being tested
- chokeberry extract
- Keywords
- oxidative stress, handball players, lipid profile, aronia, body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chokeberry extractDietary supplement
Also called Alixir400protect
The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chokeberry extract consumption | Experimental | The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. Receives: Dietary Supplement: chokeberry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superoxide anion radical
The concentration of O2- was measured after the reaction of nitro blue tetrazolium in TRIS buffer with plasma at 530 nm.
Measured: three months
hydrogen peroxide
The determination of H2O2 concentration is based on oxidation of phenol red using hydrogen peroxide, in reaction catalyzed by enzyme peroxidase from horse radish (POD). The level of H2O2 was measured at 610 nm.
Measured: three months
nitrites
Nitric oxide (•NO) decomposes rapidly to form stable metabolite nitrite/nitrate products. The method for detection of the plasma nitrite levels is based on the Griess reaction. Nitrites (NO2-) were determined as an index of NO production with Griess reagent (forms purple diazocomplex). Nitrites were measured at 550 nm.
Measured: three months
index of lipid peroxidation
The degree of lipid peroxidation in the plasma was estimated by measuring the TBARS using 1% thiobarbituric acid in 0.05 NaOH, incubated with plasma at 100 C for 15 min, and measured at 530 nm.
Measured: three months
Secondary outcomes (3)
Superoxide dismutase
SOD activity was determined by the epinephrine method of Beutler. 100 μl lysate and 1 mL of carbonate buffer were mixed; then 100 μl of epinephrine was added. Detection was performed at 470 nm.
Measured: three months
Reduced glutathione
The level of GSH was determined based on GSH oxidation with 5.5- dithio-bis-6.2-nitrobenzoic acid using the method reported by Beutler.
Measured: three months
Catalase
CAT activity was determined according to Aebi. Lysates were diluted with distilled water (1:7 v/v) and treated with chloroform-ethanol (0.6:1 v/v) to remove haemoglobin; then 50 ll of CAT buffer, 100 μl of sample, and 1 mL of 10 mM H2O2 were added to the samples. Detection was performed at 360 nm.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start4 Mar 2019
- Primary completion22 Apr 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handball PlayersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kragujevac
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidora Milosavljevic, University of Kragujevac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274582
- Sponsor's protocol ID
- Alixir400protectSportsmen
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Chokeberry Extract Supplementation on Redox Status and Body Composition in Handball Players During Competition Phase
- ClinicalTrials.gov ID
- NCT04274582
- Acronym / sponsor ID
- Alixir400protectSportsmen
- Conditions
- Handball Players
- Keywords
- oxidative stress, handball players, lipid profile, aronia, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of KragujevacUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 18 Feb 2020 (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.
The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd". All study participants were apparently healthy, had no active sports injuries, did not use any medications, and were non-smokers. Standardized questionnaires conducted under the supervision of a trained nutritionist were used to collect general data, nutritional habits and use of dietary supplements. The athletes who used any dietary supplements at least a month before the study, were excluded. All participants (or their parents if they were under the age of 18) signed an informed consent document. The study was approved by the Ethical committee of The Military Medical Academy, Belgrade.
The study was conducted during regular competition season, and lasted for twelve weeks. All participants had the same training and nutritional regime, which excluded intake of berries. The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. For the preparation of chokeberry extract (liquid form) was used fruit (berries) of Aronia melanocarpa Elliot, Rosaceae. The extract was donated by Pharmanova Belgrade, Serbia. Process of extraction is performed under specific conditions which are subject of technical patent (producer EUHEM), for the purpose of production of extract with high concentration of polyphenols. The design of the product included few demands: sufficient daily dose of polyphenols to be dietary supplement, small volume which can be consumed as shot and acceptable taste for most consumers. Compliance was monitored by the trainers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chokeberry extract consumption | Experimental | Dietary Supplement: chokeberry extractThe players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy handball players of handball club "Novi Beograd" during competition phase.
Key exclusion criteria (3 listed)
- active sports injuries,
- usage of any medications,
- smokers
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 |
|---|---|---|
| chokeberry extractAlso: Alixir400protectThe players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks. | Dietary supplement | Chokeberry extract consumption |
Primary outcome
Superoxide anion radical
Time frame: three months
The concentration of O2- was measured after the reaction of nitro blue tetrazolium in TRIS buffer with plasma at 530 nm.
hydrogen peroxide
Time frame: three months
The determination of H2O2 concentration is based on oxidation of phenol red using hydrogen peroxide, in reaction catalyzed by enzyme peroxidase from horse radish (POD). The level of H2O2 was measured at 610 nm.
nitrites
Time frame: three months
Nitric oxide (•NO) decomposes rapidly to form stable metabolite nitrite/nitrate products. The method for detection of the plasma nitrite levels is based on the Griess reaction. Nitrites (NO2-) were determined as an index of NO production with Griess reagent (forms purple diazocomplex). Nitrites were measured at 550 nm.
index of lipid peroxidation
Time frame: three months
The degree of lipid peroxidation in the plasma was estimated by measuring the TBARS using 1% thiobarbituric acid in 0.05 NaOH, incubated with plasma at 100 C for 15 min, and measured at 530 nm.
3 secondary outcomes
Superoxide dismutase
Time frame: three months
Reduced glutathione
Time frame: three months
Catalase
Time frame: three months
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 18 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Handball Players
Active, not recruiting
The Effectiveness of an Exercise Program on Scapulohumeral Rhythm, Range of Motion, and Stability in Young Female Handball Players
Scapular Dyskinesis, Handball Players
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 chokeberry extract in people with Handball Players, run by University of Kragujevac at 1 site in Serbia.
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 1 inclusion and 3 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 18 Feb 2020. 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 Serbia. 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. 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?
Superoxide anion radical (time frame: three months). The study lists 4 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 18 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.