NCT01710761

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

October 17, 2012

Last Update Submit

January 22, 2013

Conditions

Healthy

Keywords

nitric oxidecycling performancelactateVO2

Outcome Measures

Primary Outcomes (1)

  • Improved Time Trial Performance

    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 Outcomes (1)

  • Improved work efficiency

    During 20 min steady-state cycling

Study Arms (2)

Nitrate supplement with caffeine

ACTIVE COMPARATOR
Dietary Supplement: Nitrate supplement with caffeine

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

PlaceboDIETARY_SUPPLEMENT

Same form factor and flavor as test lozenge but contains no active ingredients

Placebo
Nitrate supplement with caffeineDIETARY_SUPPLEMENT

Lozenge consisting of beetroot and 75 mg caffeine

Nitrate supplement with caffeine

Eligibility Criteria

Age21 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lynne Kammer-Kerwick, MSE, MA

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 19, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)