HealthyNCT01623947
Effects of Sustamine(TM) on Cycling Time Trial Performance
A study testing 2.8 g Sustamine Beverage and 19.6 g Sustamine Beverage in people with Healthy, run by University of Texas at Austin at 1 site in United States.
Trial summary
Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2.8 g Sustamine Beverage and 19.6 g Sustamine Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 2013
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Competitive cyclist or triathlete
- Male (VO2max >= 55 ml/kg/min) or Female (VO2max >= 45 ml/kg/min)
- Healthy
- Blood pressure below 140/90
- Non-smoker
Who cannot join
- Anti-depressant medications
- Inconsistent regular medications
- Consumption performance-enhancing substances
- Type I or Type II diabetes
- Renal, hepatic or cardiac disease Current infectious disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Effects of Sustamine(TM) on Cycling Time Trial Performance Following Prolonged Cycling
Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response.
- Conditions
- Healthy
- Being tested
- Placebo Beverage, 2.8 g Sustamine Beverage, 19.6 g Sustamine Beverage
- Keywords
- glutamine, cycling performance, mental function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo BeverageDietary supplement
1400 ml flavored, colored, artificially sweetened, non-caloric beverage divided into 6 servings provided prior to and during the 2.5 hr interval ride.
2.8 g Sustamine BeverageDietary supplement
1400 ml flavored, colored, artificially sweetened, beverage containing 2.8 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride.
19.6 g Sustamine BeverageDietary supplement
1400 ml flavored, colored, artificially sweetened, beverage containing 19.6 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Beverage |
| 2.8 g Sustamine | Active comparator | Not described Receives: Dietary Supplement: 2.8 g Sustamine Beverage |
| 19.6 g Sustamine | Active comparator | Not described Receives: Dietary Supplement: 19.6 g Sustamine Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Time Trial Performance
Participants will perform an interval ride on a cycling ergometer for 2.5 hr. Intervals will be at 50% or 75% of the participant's VO2max. The time trial will consist of 4 km up a constant grade.
Measured: After 2.5 hr interval cycling
Secondary outcomes (1)
Improved Mental Function
Mental function will be assessed using a computer-based Stroop Test. Measurements will be collected before treatment, before exercise and after exercise.
Measured: After time trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Hakko Bio Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- John L. Ivy, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623947
- Sponsor's protocol ID
- 2012-03-0043
- Status last verified
- Apr 2013
- First submitted
- 18 Jun 2012
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustamine(TM) on Cycling Time Trial Performance Following Prolonged Cycling
- ClinicalTrials.gov ID
- NCT01623947
- Acronym / sponsor ID
- 2012-03-0043
- Conditions
- Healthy
- Keywords
- glutamine, cycling performance, mental function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Kyowa Hakko Bio Co., Ltd.
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (estimated)
- First posted
- 20 Jun 2012 (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.
Acute supplementation of Sustamine(TM), a combination of two amino acids, will improve cycling performance and mental acuity in a dose-dependent response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo Beverage |
| 2.8 g Sustamine | Active comparator | Dietary Supplement: 2.8 g Sustamine Beverage |
| 19.6 g Sustamine | Active comparator | Dietary Supplement: 19.6 g Sustamine Beverage |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Competitive cyclist or triathlete
- Male (VO2max >= 55 ml/kg/min) or Female (VO2max >= 45 ml/kg/min)
- Healthy
- Blood pressure below 140/90
- Non-smoker
Key exclusion criteria (5 listed)
- Anti-depressant medications
- Inconsistent regular medications
- Consumption performance-enhancing substances
- Type I or Type II diabetes
- Renal, hepatic or cardiac disease Current infectious disease
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 |
|---|---|---|
| Placebo Beverage1400 ml flavored, colored, artificially sweetened, non-caloric beverage divided into 6 servings provided prior to and during the 2.5 hr interval ride. | Dietary supplement | Placebo |
| 2.8 g Sustamine Beverage1400 ml flavored, colored, artificially sweetened, beverage containing 2.8 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride. | Dietary supplement | 2.8 g Sustamine |
| 19.6 g Sustamine Beverage1400 ml flavored, colored, artificially sweetened, beverage containing 19.6 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride. | Dietary supplement | 19.6 g Sustamine |
Primary outcome
Improved Time Trial Performance
Time frame: After 2.5 hr interval cycling
Participants will perform an interval ride on a cycling ergometer for 2.5 hr. Intervals will be at 50% or 75% of the participant's VO2max. The time trial will consist of 4 km up a constant grade.
1 secondary outcome
Improved Mental Function
Time frame: After time trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
John L. Ivy, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.8 g Sustamine Beverage and 19.6 g Sustamine Beverage in people with Healthy, run by University of Texas at Austin at 1 site in United States.
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 5 inclusion and 5 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 19 Apr 2013. 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 United States. 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.
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?
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?
Improved Time Trial Performance (time frame: After 2.5 hr interval cycling). 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 2013.