HealthyNCT01710761
Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
A study testing Nitrate supplement with caffeine in people with Healthy, run by University of Texas at Austin at 1 site in United States.
Trial summary
Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nitrate supplement with caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular commuter cyclist or spin class participant
- Male (VO2max < 50) or Female (VO2max < 45)
- Healthy
- Blood pressure below 140/90
- Non-smoker
Who cannot join
- Does not cycle 2-3 times/week
- Regular consumption of 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
Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance
- Conditions
- Healthy
- Being tested
- Placebo, Nitrate supplement with caffeine
- Keywords
- nitric oxide, cycling performance, lactate, VO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Same form factor and flavor as test lozenge but contains no active ingredients
Nitrate supplement with caffeineDietary supplement
Lozenge consisting of beetroot and 75 mg caffeine
| Study group | Role | What they receive |
|---|---|---|
| Nitrate supplement with caffeine | Active comparator | Not described Receives: Dietary Supplement: Nitrate supplement with caffeine |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Time Trial Performance
Participants will cycle 20 min at increasing intensity: 8 min at 55% VO2max, 6 min at 65% VO2max, 6 min at 75% VO2max. The 20 km time trial consists of rolling hills.
Measured: After 20 min steady-state cycling
Secondary outcomes (1)
Improved work efficiency
Expired gases will be collected and compared to expected VO2. Blood will be collected prior to treatment, prior to exercise and during each cycling intensity to analyze lactate accumulation.
Measured: During 20 min steady-state cycling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013 (estimated)
- 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Neogenis Laboratories
- Responsible party
- Sponsor
- Investigators
- Lynne Kammer-Kerwick, MSE, MA, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710761
- Sponsor's protocol ID
- 2012-05-0033
- Status last verified
- Jan 2013
- First submitted
- 17 Oct 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
- ClinicalTrials.gov ID
- NCT01710761
- Acronym / sponsor ID
- 2012-05-0033
- Conditions
- Healthy
- Keywords
- nitric oxide, cycling performance, lactate, VO2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Neogenis Laboratories
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 19 Oct 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 Neo40(TM), a nitrate lozenge, will improve cycling performance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate supplement with caffeine | Active comparator | Dietary Supplement: Nitrate supplement with caffeine |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Regular commuter cyclist or spin class participant
- Male (VO2max < 50) or Female (VO2max < 45)
- Healthy
- Blood pressure below 140/90
- Non-smoker
Key exclusion criteria (5 listed)
- Does not cycle 2-3 times/week
- Regular consumption of 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 |
|---|---|---|
| PlaceboSame form factor and flavor as test lozenge but contains no active ingredients | Dietary supplement | Placebo |
| Nitrate supplement with caffeineLozenge consisting of beetroot and 75 mg caffeine | Dietary supplement | Nitrate supplement with caffeine |
Primary outcome
Improved Time Trial Performance
Time frame: After 20 min steady-state cycling
Participants will cycle 20 min at increasing intensity: 8 min at 55% VO2max, 6 min at 65% VO2max, 6 min at 75% VO2max. The 20 km time trial consists of rolling hills.
1 secondary outcome
Improved work efficiency
Time frame: During 20 min steady-state cycling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
Lynne Kammer-Kerwick, MSE, MA principal investigator
The 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 Nitrate supplement with caffeine 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 23 Jan 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 20 min steady-state 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 23 Jan 2013.