New Protein Bar for Physically Active People

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007731
• Other study ID #: barsport
• Status: Completed
• Phase: N/A
• 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
• 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At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.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

Related Conditions & MeSH terms

• Inflammation
• Muscle Mass
• Regeneration Muscle

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