We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University of Texas at Austin.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01710761
First Posted: October 19, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Neogenis Laboratories
Information provided by (Responsible Party):
University of Texas at Austin
  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
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

Resource links provided by NLM:


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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: October 17, 2012
First Posted: October 19, 2012
Last Update Posted: October 12, 2017
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