Back to resultsNew Protein Bar for Physically Active People
Primary Purpose
Muscle Mass, Inflammation, Regeneration Muscle
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
DrRip - high protein, high fibre and creatine load
Voltage energy bar
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Mass focused on measuring protein bar, physical activity, muscle
Eligibility Criteria
Inclusion Criteria:
- daily high-intensity physical activity
Exclusion Criteria:
- smoking, cardiovascular, neurological, skeletal muscle disease, allergies
Sites / Locations
- University of Primorska, Faculty of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High protein, high fibre and creatine load bar (DrRip)
Voltage energy bar
Arm Description
1 new protein bar (260 kcal) after training every day
1 control commercially available protein bar (260 kcal) after training every day
Outcomes
Primary Outcome Measures
Muscle mass
Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Fat mass
Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Secondary Outcome Measures
C-reactive protein
Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111).
Creatine kinase
Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Lactate dehydrogenase
Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Tumor necrosis factor alpha
Serum levels of Tumor necrosis factor alpha (parameter of inflammation) will be analyzed by enzyme linked immunosorbent assays (ELISA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04007731
Brief Title
New Protein Bar for Physically Active People
Official Title
Effects of New Protein Bar on Biochemical and Physiological Parameters in Physically Active People
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zala Jenko Praznikar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Mass, Inflammation, Regeneration Muscle
Keywords
protein bar, physical activity, muscle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High protein, high fibre and creatine load bar (DrRip)
Arm Type
Experimental
Arm Description
1 new protein bar (260 kcal) after training every day
Arm Title
Voltage energy bar
Arm Type
Active Comparator
Arm Description
1 control commercially available protein bar (260 kcal) after training every day
Intervention Type
Dietary Supplement
Intervention Name(s)
DrRip - high protein, high fibre and creatine load
Other Intervention Name(s)
Protein product
Intervention Description
A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
Intervention Type
Dietary Supplement
Intervention Name(s)
Voltage energy bar
Other Intervention Name(s)
control protein bar
Intervention Description
A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
Primary Outcome Measure Information:
Title
Muscle mass
Description
Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Time Frame
15 days
Title
Fat mass
Description
Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Time Frame
15 days
Secondary Outcome Measure Information:
Title
C-reactive protein
Description
Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111).
Time Frame
15 days
Title
Creatine kinase
Description
Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Time Frame
15 days
Title
Lactate dehydrogenase
Description
Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Time Frame
15 days
Title
Tumor necrosis factor alpha
Description
Serum levels of Tumor necrosis factor alpha (parameter of inflammation) will be analyzed by enzyme linked immunosorbent assays (ELISA).
Time Frame
15 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
daily high-intensity physical activity
Exclusion Criteria:
smoking, cardiovascular, neurological, skeletal muscle disease, allergies
Facility Information:
Facility Name
University of Primorska, Faculty of Health Sciences
City
Izola
ZIP/Postal Code
SI-6310
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers on the study (Saša Kenig, Ana Petelin, Tadeja Jakus) will analyze samples, which will be coded by PI
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New Protein Bar for Physically Active People
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