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Completed

NCT Number: NCT04007731

New Protein Bar for Physically Active People

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.

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Key information

Conditions

Muscle Mass Behavior Inflammation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Regeneration Muscle

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska, Faculty of Health Sciences

Izola, SI-6310, Slovenia

About this study

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At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • daily high-intensity physical activity

Exclusion criteria

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

Treatment and study plan

DrRip - high protein, high fibre and creatine load

Dietary Supplement

A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption

Other names: Protein product

Voltage energy bar

Dietary Supplement

A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption

Other names: control protein bar

Primary outcomes

  1. Muscle mass

    Time frame: 15 days

    Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

  2. Fat mass

    Time frame: 15 days

    Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

Secondary outcomes

  1. C-reactive protein

    Time frame: 15 days

    Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111).

  2. Creatine kinase

    Time frame: 15 days

    Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).

  3. Lactate dehydrogenase

    Time frame: 15 days

    Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).

  4. Tumor necrosis factor alpha

    Time frame: 15 days

    Serum levels of Tumor necrosis factor alpha (parameter of inflammation) will be analyzed by enzyme linked immunosorbent assays (ELISA).

Sponsors and collaborators

Lead sponsor

Zala Jenko Praznikar

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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