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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Neogenis Labs
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01710761
First received: October 17, 2012
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Healthy
 Dietary Supplement: Placebo
Dietary Supplement: Nitrate supplement with caffeine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Neo40(TM) With Caffeine on Cycling Time Trial Performance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Improved Time Trial Performance [ Time Frame: After 20 min steady-state cycling ] [ Designated as safety issue: No ]
    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:
  • Improved work efficiency [ Time Frame: During 20 min steady-state cycling ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 16
Study Start Date: October 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 49 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Labs
Investigators
Principal Investigator: Lynne Kammer-Kerwick, MSE, MA The University of Texas at Austin
  More Information

No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01710761     History of Changes
Other Study ID Numbers: 2012-05-0033
Study First Received: October 17, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013