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

January 22, 2013 updated by: University of Texas at Austin
Acute supplementation of Neo40(TM), a nitrate lozenge, will improve cycling performance

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 20 min steady-state cycling

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During 20 min steady-state cycling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Neogenis Laboratories

Investigators

  • Principal Investigator: Lynne Kammer-Kerwick, MSE, MA, The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-05-0033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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