New Protein Bar for Physically Active People

Not Applicable

Completed

• Conditions: Muscle Mass; Inflammation; Regeneration Muscle

• Registration Number: NCT04007731
• Lead Sponsor: Zala Jenko Praznikar

Brief 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.

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At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.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

Study Timeline

• Study First Submitted: 2019-06-21
• Study Start: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Primary Completion: 2019-12-05
• Study Completion: 2020-02-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• daily high-intensity physical activity

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fat mass	15 days	Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Muscle mass	15 days	Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	15 days	Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111).
Lactate dehydrogenase	15 days	Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Tumor necrosis factor alpha	15 days	Serum levels of Tumor necrosis factor alpha (parameter of inflammation) will be analyzed by enzyme linked immunosorbent assays (ELISA).
Creatine kinase	15 days	Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).

Trial Locations

Locations (1)

University of Primorska, Faculty of Health Sciences; 🇸🇮 Izola, Slovenia