Muscle MassNCT04007731
New Protein Bar for Physically Active People
A study testing DrRip - high protein, high fibre and creatine load and Voltage energy bar in people with Muscle Mass and Inflammation, run by Zala Jenko Praznikar at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass, Inflammation, Regeneration Muscle
- What is being tested?
- DrRip - high protein, high fibre and creatine load and Voltage energy bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jul 2019to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- daily high-intensity physical activity
Who cannot join
- smoking, cardiovascular, neurological, skeletal muscle disease, allergies
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, SI-6310
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Mass, Inflammation, Regeneration Muscle
- Being tested
- DrRip - high protein, high fibre and creatine load, Voltage energy bar
- Keywords
- protein bar, physical activity, muscle
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrRip - high protein, high fibre and creatine loadDietary supplement
Also called Protein product
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 barDietary supplement
Also called control protein bar
A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
| Study group | Role | What they receive |
|---|---|---|
| High protein, high fibre and creatine load bar (DrRip) | Experimental | 1 new protein bar (260 kcal) after training every day Receives: Dietary Supplement: DrRip - high protein, high fibre and creatine load |
| Voltage energy bar | Active comparator | 1 control commercially available protein bar (260 kcal) after training every day Receives: Dietary Supplement: Voltage energy bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Measured: 15 days
Fat mass
Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Measured: 15 days
Secondary outcomes (4)
C-reactive protein
Serum levels of C-reactive protein (parameter of inflammation) will be analyzed by biochemistry analyzer (Cobass c111).
Measured: 15 days
Creatine kinase
Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Measured: 15 days
Lactate dehydrogenase
Serum levels of creatine kinase (marker of regeneration) will be analyzed by biochemistry analyzer (Cobass c111).
Measured: 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).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jul 2019
- Primary completion5 Dec 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle MassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zala Jenko Praznikar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zala Jenko Praznikar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007731
- Sponsor's protocol ID
- barsport
- Status last verified
- Mar 2020
- First submitted
- 21 Jun 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers on the study (Saša Kenig, Ana Petelin, Tadeja Jakus) will analyze samples, which will be coded by PI
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of New Protein Bar on Biochemical and Physiological Parameters in Physically Active People
- ClinicalTrials.gov ID
- NCT04007731
- Acronym / sponsor ID
- barsport
- Conditions
- Muscle Mass, Inflammation, Regeneration Muscle
- Keywords
- protein bar, physical activity, muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zala Jenko PraznikarUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein, high fibre and creatine load bar (DrRip) | Experimental | Dietary Supplement: DrRip - high protein, high fibre and creatine load1 new protein bar (260 kcal) after training every day |
| Voltage energy bar | Active comparator | Dietary Supplement: Voltage energy bar1 control commercially available protein bar (260 kcal) after training every day |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- daily high-intensity physical activity
Key exclusion criteria (1 listed)
- smoking, cardiovascular, neurological, skeletal muscle disease, allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrRip - high protein, high fibre and creatine loadAlso: Protein productA protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption | Dietary supplement | High protein, high fibre and creatine load bar (DrRip) |
| Voltage energy barAlso: control protein barA protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption | Dietary supplement | Voltage energy bar |
Primary outcome
Muscle mass
Time frame: 15 days
Muscle mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
Fat mass
Time frame: 15 days
Fat mass in kilograms will be determined using bioelectrical impedance analysis (BIA).
4 secondary outcomes
C-reactive protein
Time frame: 15 days
Creatine kinase
Time frame: 15 days
Lactate dehydrogenase
Time frame: 15 days
Tumor necrosis factor alpha
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No. Other researchers on the study (Saša Kenig, Ana Petelin, Tadeja Jakus) will analyze samples, which will be coded by PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DrRip - high protein, high fibre and creatine load and Voltage energy bar in people with Muscle Mass and Inflammation, run by Zala Jenko Praznikar at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.