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

Sponsor

University of Texas at Austin (Other)

Overall Status

Unknown status

CT.gov ID

NCT01710761

Collaborator

Neogenis Laboratories (Other)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Placebo Dietary Supplement: Nitrate supplement with caffeine	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2012

Anticipated Primary Completion Date :

Feb 1, 2013

Anticipated Study Completion Date :

May 1, 2013

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

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

Improved Time Trial Performance [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 [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

Criteria

Ages Eligible for Study:

21 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT01710761

Other Study ID Numbers:

2012-05-0033

First Posted:

Oct 19, 2012

Last Update Posted:

Jan 23, 2013

Last Verified:

Jan 1, 2013

Keywords provided by University of Texas at Austin

Additional relevant MeSH terms:

Caffeine

Study Results

No Results Posted as of Jan 23, 2013