New Protein Bar for Physically Active People

Effects of New Protein Bar on Biochemical and Physiological Parameters in 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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Muscle Mass; Regeneration Muscle
• Intervention / Treatment: Dietary supplement: DrRip - high protein, high fibre and creatine load; Dietary supplement: Voltage energy 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At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Izola, Slovenia, SI-6310
    • University of Primorska, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• daily high-intensity physical activity

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High protein, high fibre and creatine load bar (DrRip); 1 new protein bar (260 kcal) after training every day	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; Other Names: Protein product
ACTIVE_COMPARATOR: Voltage energy bar; 1 control commercially available protein bar (260 kcal) after training every day	Dietary supplement: 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; Other Names: control protein bar

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zala Jenko Praznikar

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): December 5, 2019
• Study Completion (ACTUAL): February 20, 2020

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; muscle; protein bar
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: barsport

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Other researchers on the study (Saša Kenig, Ana Petelin, Tadeja Jakus) will analyze samples, which will be coded by PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No