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Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance

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ClinicalTrials.gov Identifier: NCT01710761
Recruitment Status : Unknown
Verified January 2013 by University of Texas at Austin.
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2012
Last Update Posted : January 23, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance

Condition or disease Intervention/treatment
Healthy Dietary Supplement: Placebo Dietary Supplement: Nitrate supplement with caffeine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance
Study Start Date : October 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Nitrate supplement with caffeine Dietary Supplement: Nitrate supplement with caffeine
Lozenge consisting of beetroot and 75 mg caffeine
Placebo Comparator: Placebo Dietary Supplement: Placebo
Same form factor and flavor as test lozenge but contains no active ingredients


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Improved work efficiency [ Time Frame: During 20 min steady-state cycling ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710761


Locations
United States, Texas
The University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Neogenis Laboratories
Investigators
Principal Investigator: Lynne Kammer-Kerwick, MSE, MA The University of Texas at Austin
More Information

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01710761     History of Changes
Other Study ID Numbers: 2012-05-0033
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by University of Texas at Austin:
nitric oxide
cycling performance
lactate
VO2

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents