This trial is active, not recruiting.

Condition healthy
Treatments placebo, nitrate supplement with caffeine
Sponsor University of Texas at Austin
Collaborator Neogenis Laboratories
Start date October 2012
End date February 2013
Trial size 16 participants
Trial identifier NCT01710761, 2012-05-0033


Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
(Active Comparator)
nitrate supplement with caffeine
Lozenge consisting of beetroot and 75 mg caffeine
(Placebo Comparator)
Same form factor and flavor as test lozenge but contains no active ingredients

Primary Outcomes

Improved Time Trial Performance
time frame: After 20 min steady-state cycling

Secondary Outcomes

Improved work efficiency
time frame: During 20 min steady-state cycling

Eligibility Criteria

Male or female participants from 21 years up to 49 years old.

Inclusion Criteria: - Regular commuter cyclist or spin class participant - Male (VO2max < 50) or Female (VO2max < 45) - Healthy - Blood pressure below 140/90 - Non-smoker Exclusion Criteria: - 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

Additional Information

Official title Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
Principal investigator Lynne Kammer-Kerwick, MSE, MA
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Texas at Austin.