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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04007731
Other study ID # barsport
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date February 20, 2020

Study information

Verified date March 2020
Source University of Primorska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Post-exercise nutrition is an important factor in a nutrition plan for physically active subjects. Focusing on that, the Serbian group is developing protein bars enriched with sports supplements. Slovenian partner group will investigate the effect of new protein bar consumption on body composition, biochemical parameters, and muscle regeneration after training. The new bar will be compared with a commercially available bar.


Description:

The clinical study will be performed on 10 elite handball players from Slovenia handball club. It will be designed as a crossover study. Half of the participants will consume the new bar for five days and the other half will consume the control bar. After the five-day washout period, the groups will consume the bar which was not consumed in the first period.

At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.

The analyzed biochemical parameters will be basic serum parameters, such as fasting glucose, total cholesterol, LDL, HDL, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), C-reactive protein (CRP), and parameters related to the muscle regeneration and inflammation, such as creatine kinase, lactate dehydrogenase, insulin-like growth factor (IGF), tumor necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), monocyte chemoattractant protein 1 (MCP-1).

In the second part of the study, the acute effect of consuming each bar after training will be tested. Each participant will consume both bars on separate days. The mentioned parameters will be assessed after training and immediately and 3h after bar consumption.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 20, 2020
Est. primary completion date December 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- daily high-intensity physical activity

Exclusion Criteria:

- smoking, cardiovascular, neurological, skeletal muscle disease, allergies

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
DrRip - high protein, high fibre and creatine load
A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
Voltage energy bar
A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption

Locations

Country Name City State
Slovenia University of Primorska, Faculty of Health Sciences Izola

Sponsors (1)

Lead Sponsor Collaborator
Zala Jenko Praznikar

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle mass Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA). 15 days
Primary Fat mass Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA). 15 days
Secondary C-reactive protein Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111). 15 days
Secondary Creatine kinase Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111). 15 days
Secondary Lactate dehydrogenase Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111). 15 days
Secondary Tumor necrosis factor alpha Serum levels of Tumor necrosis factor alpha (parameter of inflammation) will be analyzed by enzyme linked immunosorbent assays (ELISA). 15 days
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