The Influences of Chokeberry Extract Supplementation on Handball Players

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.

Study Overview

• Status: Completed
• Conditions: Handball Players
• Intervention / Treatment: Dietary supplement: chokeberry extract

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Kragujevac, Serbia
    • Faculty of Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chokeberry extract consumption; The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.	Dietary supplement: chokeberry extract; The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.; Other Names: Alixir400protect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	three months

Collaborators and Investigators

• Sponsor: University of Kragujevac

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: body composition; oxidative stress; lipid profile; aronia; handball players
• Other Study ID Numbers: Alixir400protectSportsmen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No