The Influences of Chokeberry Extract Supplementation on Handball Players

NCT ID: NCT04274582

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2019-06-03

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.

Conditions

Handball Players

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Chokeberry extract consumption

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

Group Type: EXPERIMENTAL

chokeberry extract

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

chokeberry extract

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Alixir400protect

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kragujevac

OTHER

Sponsor Role: lead

Responsible Party

Isidora Milosavljevic

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medical Science

Kragujevac, , Serbia

Countries

Serbia

Other Identifiers

Alixir400protectSportsmen

Identifier Type: -

Identifier Source: org_study_id