The Influences of Chokeberry Extract Supplementation on Handball Players

Handball Players Clinical Trial

Official title:

The Influences of Chokeberry Extract Supplementation on Redox Status and Body Composition in Handball Players During Competition Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274582
• Other study ID #: Alixir400protectSportsmen
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: June 3, 2019

Study information

• Verified date: February 2020
• Source: University of Kragujevac
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 3, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 24 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• active sports injuries,

• usage of any medications,

• smokers

Related Conditions & MeSH terms

• Handball Players

Intervention

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

Locations

Country	Name	City	State
Serbia	Faculty of Medical Science	Kragujevac

Sponsors (1)

Lead Sponsor	Collaborator
University of Kragujevac

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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