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New Protein Bar for Physically Active People

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04007731
Enrollment
10
Registered
2019-07-05
Start date
2019-07-01
Completion date
2020-02-20
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Muscle Mass, Regeneration Muscle

Keywords

protein bar, physical activity, muscle

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 At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.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

Interventions

DIETARY_SUPPLEMENTDrRip - 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

DIETARY_SUPPLEMENTVoltage 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

Sponsors

Zala Jenko Praznikar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* daily high-intensity physical activity

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle mass15 daysMuscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Fat mass15 daysFat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).

Secondary

MeasureTime frameDescription
C-reactive protein15 daysSerum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111).
Creatine kinase15 daysSerum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Lactate dehydrogenase15 daysSerum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Tumor necrosis factor alpha15 daysSerum levels of Tumor necrosis factor alpha (parameter of inflammation) will be analyzed by enzyme linked immunosorbent assays (ELISA).

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026