Sports InjuryNCT03121040
Clinical Trial for Vespa Amino Acid Mixture (VAAM®)
A study testing Vespa amino acid mixture in people with Sports Injury, run by Shanghai Meiji Health Science and Technology Co., Ltd..
Trial summary
ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then followed by the generation of lactic acid. However, this process can only be maintained for a short time, approximately one minute, because the accumulation of lactic acid in the muscles may affect muscle performance. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury
- What is being tested?
- Vespa amino acid mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2009to 22 Jul 2009
- 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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Athletes from 16 to 18 years old;
- Subjects underwent a physical examination before enrollment and showed no sign of illness or malaise.
Who cannot join
- Subjects were smokers or ergogenic aid users;
- Subjects had any metabolic, cardiovascular, renal, or liver diseases;
- Subjects had psychiatric disorders.
About this study
Official title: Improved ATP Generation Efficiency for Younger Athletes by Ingestion of a Vespa Amino Acid Mixture
ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then followed by the generation of lactic acid. However, this process can only be maintained for a short time, approximately one minute, because the accumulation of lactic acid in the muscles may affect muscle performance. The efficiency of lactic acid metabolism is one of the most important reasons for endurance improvement. The purpose of this study was to evaluate the impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®) beverage on blood parameters that are related to fatigue, muscle damage and immunity in healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive required speed and strength running tests.
Read the detailed description
The subjects were instructed to maintain their usual dietary habits in addition to drinking VAAM® (two cans every day) for 10 weeks. In detail, on the 6 days/week of supervised running tests, participants were instructed to consume one drink before their warm-up exercise and the other drink while running. During their sessions and without supervision (1 day/week), participants were also instructed to consume one drink in the morning after breakfast and the other drink in the evening after dinner.
The subjects were divided into three groups for the running tests: 3 males were assigned to group 1, which involved training for the 1500-meter race; 2 males were assigned to group 2, which involved training for the 800-meter race; and 1 male and 3 females were assigned to group 3, which involved training for the 400-meter race. The running exercises began with a 45 min warm-up (including jogging, leg stretching, etc.) followed by running their specific races. The experimental procedure was conducted 6 days/week for 10 weeks.
- Conditions
- Sports Injury
- Being tested
- Vespa amino acid mixture
- Keywords
- Vespa amino acid mixture (VAAM®), Young athletes, Nutrition, lactic acid accumulation, Anaerobic metabolism, ATP, Sports damage
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vespa amino acid mixtureDietary supplement
Also called VAAM®
17 kinds of amino acids mixture in specific proportion
| Study group | Role | What they receive |
|---|---|---|
| Subjects ingested VAAM® for 10 weeks | Experimental | Ten young athletes ingested Vespa amino acid mixture (VAAM®) for 10 weeks, divided into different meter race including 1500-, 800- and 400-meter races. Receives: Dietary Supplement: Vespa amino acid mixture |
| Subjects ingested VAAM® for 6 weeks | Experimental | Ten young athletes ingested Vespa amino acid mixture (VAAM®) for 6 weeks, divided into different meter race including 1500-, 800- and 400-meter races. Receives: Dietary Supplement: Vespa amino acid mixture |
| Subjects ingested nothing | No intervention | Ten young athletes before ingesting Vespa amino acid mixture (VAAM®) , divided into different meter race including 1500-, 800- and 400-meter races. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of running time scores at 10 weeks
Measured: 10 weeks
change of the plasma lactic acid clearance rate after running at 10 weeks
Measured: 10 weeks
change of red blood cells after running at 10 weeks
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start2 May 2009
- Primary completion16 Jul 2009
- Study completion22 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports InjuryStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121040
- Sponsor's protocol ID
- 0002
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved ATP Generation Efficiency for Younger Athletes by Ingestion of a Vespa Amino Acid Mixture
- ClinicalTrials.gov ID
- NCT03121040
- Acronym / sponsor ID
- 0002
- Conditions
- Sports Injury
- Keywords
- Vespa amino acid mixture (VAAM®), Young athletes, Nutrition, lactic acid accumulation, Anaerobic metabolism, ATP, Sports damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 May 2009 (actual)
- Primary completion
- 16 Jul 2009 (actual)
- Study completion
- 22 Jul 2009 (actual)
- First posted
- 19 Apr 2017 (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.
ATP is generated mainly through anaerobic metabolism during strenuous exercise, which is then followed by the generation of lactic acid. However, this process can only be maintained for a short time, approximately one minute, because the accumulation of lactic acid in the muscles may affect muscle performance. The efficiency of lactic acid metabolism is one of the most important reasons for endurance improvement. The purpose of this study was to evaluate the impacts of the daily ingestion of a commercially available Vespa amino acid mixture (VAAM®) beverage on blood parameters that are related to fatigue, muscle damage and immunity in healthy, young athletes during middle-distance running exercises. VAAM® contains 17 types of amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive required speed and strength running tests.
Detailed description
The subjects were instructed to maintain their usual dietary habits in addition to drinking VAAM® (two cans every day) for 10 weeks. In detail, on the 6 days/week of supervised running tests, participants were instructed to consume one drink before their warm-up exercise and the other drink while running. During their sessions and without supervision (1 day/week), participants were also instructed to consume one drink in the morning after breakfast and the other drink in the evening after dinner.
The subjects were divided into three groups for the running tests: 3 males were assigned to group 1, which involved training for the 1500-meter race; 2 males were assigned to group 2, which involved training for the 800-meter race; and 1 male and 3 females were assigned to group 3, which involved training for the 400-meter race. The running exercises began with a 45 min warm-up (including jogging, leg stretching, etc.) followed by running their specific races. The experimental procedure was conducted 6 days/week for 10 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects ingested VAAM® for 10 weeks | Experimental | Dietary Supplement: Vespa amino acid mixtureTen young athletes ingested Vespa amino acid mixture (VAAM®) for 10 weeks, divided into different meter race including 1500-, 800- and 400-meter races. |
| Subjects ingested VAAM® for 6 weeks | Experimental | Dietary Supplement: Vespa amino acid mixtureTen young athletes ingested Vespa amino acid mixture (VAAM®) for 6 weeks, divided into different meter race including 1500-, 800- and 400-meter races. |
| Subjects ingested nothing | No intervention | –Ten young athletes before ingesting Vespa amino acid mixture (VAAM®) , divided into different meter race including 1500-, 800- and 400-meter races. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Athletes from 16 to 18 years old;
- Subjects underwent a physical examination before enrollment and showed no sign of illness or malaise.
Key exclusion criteria (3 listed)
- Subjects were smokers or ergogenic aid users;
- Subjects had any metabolic, cardiovascular, renal, or liver diseases;
- Subjects had psychiatric disorders.
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 |
|---|---|---|
| Vespa amino acid mixtureAlso: VAAM®17 kinds of amino acids mixture in specific proportion | Dietary supplement | Subjects ingested VAAM® for 10 weeks, Subjects ingested VAAM® for 6 weeks |
Primary outcome
change of running time scores at 10 weeks
Time frame: 10 weeks
change of the plasma lactic acid clearance rate after running at 10 weeks
Time frame: 10 weeks
change of red blood cells after running at 10 weeks
Time frame: 10 weeks
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 19 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vespa amino acid mixture in people with Sports Injury, run by Shanghai Meiji Health Science and Technology Co., Ltd..
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 2 inclusion and 3 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
change of running time scores at 10 weeks (time frame: 10 weeks). The study lists 3 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 19 Apr 2017.