NCT04274582

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 12, 2020

Last Update Submit

February 17, 2020

Conditions

Handball Players

Keywords

oxidative stresshandball playerslipid profilearoniabody composition

Outcome Measures

Primary Outcomes (4)

  • Superoxide anion radical

    The concentration of O2- was measured after the reaction of nitro blue tetrazolium in TRIS buffer with plasma at 530 nm.

    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.

    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.

    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.

    three months

Secondary Outcomes (3)

  • Superoxide dismutase

    three months

  • Reduced glutathione

    three months

  • Catalase

    three months

Study Arms (1)

Chokeberry extract consumption

EXPERIMENTAL

The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.

Dietary Supplement: chokeberry extract

Interventions

chokeberry extractDIETARY_SUPPLEMENT

The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.

Also known as: Alixir400protect
Chokeberry extract consumption

Eligibility Criteria

Age16 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIn study the male handball players were onlz included.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy handball players of handball club "Novi Beograd" during competition phase.

You may not qualify if:

  • active sports injuries,
  • usage of any medications,
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medical Science

Kragujevac, Serbia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 18, 2020

Study Start

March 4, 2019

Primary Completion

April 22, 2019

Study Completion

June 3, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)