New Protein Bar for Physically Active People

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 At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.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

Official Title
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Effects of New Protein Bar on Biochemical and Physiological Parameters in Physically Active People

Conditions
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Muscle Mass, Inflammation, Regeneration Muscle

Intervention / Treatment
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* Dietary Supplement: DrRip - high protein, high fibre and creatine load
* Dietary Supplement: Voltage energy bar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: daily high-intensity physical activity Exclusion Criteria: smoking, cardiovascular, neurological, skeletal muscle disease, allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High protein, high fibre and creatine load bar (DrRip)<br>1 new protein bar (260 kcal) after training every day | Dietary Supplement: DrRip - high protein, high fibre and creatine load<br>* A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption<br>* Other names: Protein product;|
| Active Comparator: Voltage energy bar<br>1 control commercially available protein bar (260 kcal) after training every day | Dietary Supplement: Voltage energy bar<br>* A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption<br>* Other names: control protein bar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA). | 15 days | 
| Fat mass | Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA). | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111). | 15 days | 
| Creatine kinase | Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111). | 15 days | 
| Lactate dehydrogenase | Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111). | 15 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein bar, physical activity, muscle