ContractureEarly Phase 1SPORTEUSNCT02385357
Effect of a Protein-enriched Drink on Muscle Function
A Early Phase 1 study testing Protein-enriched drink in people with Contracture, run by Puleva Biotech at 1 site in Spain.
Trial summary
There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contracture
- What is being tested?
- Protein-enriched drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Dec 2015
- Phase
- Early Phase 1
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreational triathletes with 2 years of experience
- Maximum oxygen uptake : ≥55 ml/kg/min
- Fat mass: 8-20% measured by dual energy x-ray absorptiometry
- Not participating in another study
- Not having ergogenic aids
- Not participating in a weight loss program
- Normal electrocardiogram
- Participants must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment
Who cannot join
- History of cardiovascular disease
- Diabetes or hypertension
- Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
- Smoking
- Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.
- Unwillingness to either complete the study requirements or to be randomized into control or training group.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Biosearch Life
Granada, Granada, 18004
Federico Lara, PhD, 0034958240100, Federico.LaraVilloslada@puleva.es
About this study
Official title: Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout
There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. The present counterbalanced, crossover, and double blind study will involve a total of 12 active men.
Read the detailed description
Participants will run downhill (-10%) during 30 min at a intensity equivalent to 75-80% of their maximum heart rate (previously determined). After the exercise bout, participants will have either the placebo or the experimental drink. The investigators will measure muscle function and damage-related parameters right after the exercise as well as the three following days. This protocol will be repeated after a wash out period of 3 weeks, where the participants will have the other drink. The investigators will control exercise and diet three weeks before study entry, during the experimental week as the investigators as during the wash out period.
- Conditions
- Contracture
- Being tested
- Protein-enriched drink
- Keywords
- Muscle function, Anaerobic power, Muscle damage
- Medical subject headings
- Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein-enriched drinkDietary supplement
Participants will drink 330 ml of a protein-enriched drink (6 g/ml of protein) after a high intensity exercise that induce muscle damage (30 min running downhill with a slope of -10º)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein) |
| Experimental | Experimental | 330 ml of protein-enriched drink (6 g/100 ml of protein) Receives: Dietary Supplement: Protein-enriched drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric muscle strength
Isometric muscle strength of lower limbs at 90% angle.
Measured: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Secondary outcomes (6)
Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.
Muscle soreness of the lower limbs will be self-reported by a visual anagogic scale and with an algometer score.
Measured: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Power output assessed with the 30sec. Wingate anaerobic test
Power output will be assessed with the 30sec. Wingate anaerobic test.
Measured: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Creatine kinase
Creatine kinase will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout
Measured: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Urine Creatinine
Concentration of creatinine in urine will be assessed after the protein-enriched drink to assess muscle recovery after a high intensity exercise bout
Measured: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Resting metabolic rate
Measured: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)
We will measure the time that the participant is able to run 90% of his determined maximum aerobic velocity
Measured: 24hrs after protein-enriched drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContractureStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puleva Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada
- Responsible party
- Sponsor
- Investigators
- Federico Lara, PhD, Study director, Puleva Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385357
- Sponsor's protocol ID
- Puleva
- Acronym
- SPORTEUS
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Protein-enriched Drink on Muscle Function Recovery Following an Acute High Intensity Exercise Bout
- ClinicalTrials.gov ID
- NCT02385357
- Acronym / sponsor ID
- SPORTEUS / Puleva
- Conditions
- Contracture
- Keywords
- Muscle function, Anaerobic power, Muscle damage
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Puleva BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Universidad de Granada
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Mar 2015 (estimated)
- 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.
There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. The present counterbalanced, crossover, and double blind study will involve a total of 12 active men.
Detailed description
Participants will run downhill (-10%) during 30 min at a intensity equivalent to 75-80% of their maximum heart rate (previously determined). After the exercise bout, participants will have either the placebo or the experimental drink. The investigators will measure muscle function and damage-related parameters right after the exercise as well as the three following days. This protocol will be repeated after a wash out period of 3 weeks, where the participants will have the other drink. The investigators will control exercise and diet three weeks before study entry, during the experimental week as the investigators as during the wash out period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | –330 ml of commercial protein-enriched drink (2.5 g/100 ml of protein) |
| Experimental | Experimental | Dietary Supplement: Protein-enriched drink330 ml of protein-enriched drink (6 g/100 ml of protein) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Recreational triathletes with 2 years of experience
- Maximum oxygen uptake : ≥55 ml/kg/min
- Fat mass: 8-20% measured by dual energy x-ray absorptiometry
- Not participating in another study
- Not having ergogenic aids
Key exclusion criteria (6 listed)
- History of cardiovascular disease
- Diabetes or hypertension
- Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
- Smoking
- Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.
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 |
|---|---|---|
| Protein-enriched drinkParticipants will drink 330 ml of a protein-enriched drink (6 g/ml of protein) after a high intensity exercise that induce muscle damage (30 min running downhill with a slope of -10º) | Dietary supplement | Experimental |
Primary outcome
Isometric muscle strength
Time frame: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Isometric muscle strength of lower limbs at 90% angle.
6 secondary outcomes
Muscle soreness of lower limbs self-reported by a visual anagogic scale and with an algometer score.
Time frame: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Power output assessed with the 30sec. Wingate anaerobic test
Time frame: Change from post- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Creatine kinase
Time frame: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Urine Creatinine
Time frame: Change from post- protein-enriched drink to 24, 48 hrs post- protein-enriched drink
Resting metabolic rate
Time frame: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink
Time limit (time that the participant is able to run 90% of his determined maximum aerobic velocity)
Time frame: 24hrs after protein-enriched drink
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Federico Lara, PhD study director
Puleva Biotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Protein-enriched drink in people with Contracture, run by Puleva Biotech at 1 site in Spain.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Lara, PhD (0034958240100, Federico.LaraVilloslada@puleva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric muscle strength (time frame: Change from pre- protein-enriched drink to 24, 48 and 72 hrs post- protein-enriched drink). 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 11 Mar 2015.