NCT03019523

Brief Summary

This is a cross-over design study in which subjects arrived to the lab and were assigned a supplement to ingest. Prior to ingestion subjects completed baseline reaction time testing along with a questionnaire. Thirty minutes after ingestion subjects filled out the same questionnaire, completed a reaction time test, followed by a series of dynamic exercises. After the last exercise was finished subjects filled out the questionnaire, completed another reaction time test and repeated the series of dynamic exercises. Following the exercises, subjects filled out the questionnaire and completed a fourth round of reaction time testing. In total subjects would complete 2 rounds of dynamic exercises and 4 rounds of reaction time testing with heart rate being recorded before and after the dynamic exercise rounds. Subjects were told to wash-out for 7 days and return to the lab to complete the same testing but on the alternative supplement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

December 15, 2016

Last Update Submit

January 24, 2017

Conditions

Keywords

caffeinemental performancereaction timefocus

Outcome Measures

Primary Outcomes (3)

  • Response to Caffeine on Measures of Reaction Time by Makoto

    The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of reaction time in athletic populations.

    up to 4 hours

  • Response to Caffeine on Measures of Mental Performance by Survey in Athletic Populatons

    The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of mental performance in athletic populations.

    up to 4 hours

  • Response to Caffeine on Measures of Cognitive Fatigue by Survey in Athletic Populatons

    The primary purpose of this investigation is to determine if acute ingestion of a proprietary supplement containing caffeine, theanine, and tyrosine has any positive effects on markers of cognitive fatigue in athletic populations.

    up to 4 hours

Secondary Outcomes (1)

  • Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed

    up to 4 hours

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Maltodextrin (\~2 grams to match weight of active treatment) placebo pre-testing (1 dose w/3 oz of water) 30 minutes following ingestion exercise and Makoto testing were completed.

Other: Sugar Pill

Caffeine Blend

ACTIVE COMPARATOR

75 mg caffeine, 75 mg theanine, and 2g tyrosine pre-testing (1 dose w/3 oz of water) 30 minutes following ingestion exercise and Makoto testing were completed.

Dietary Supplement: Caffeine Blend

Interventions

Caffeine BlendDIETARY_SUPPLEMENT

Taken orally in capsule form

Caffeine Blend

Taken orally in capsule form

Sugar Pill

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be males between the ages of 18-25 years
  • Subjects will be team sport athletes or highly trained
  • Subjects will not be able to smoke or use tobacco
  • Subjects has provided written and dated informed consent to participate in the study
  • Subjects is willing and able to comply with the protocol
  • Subjects is apparently healthy and free from disease, as determined by a health history questionnaire
  • Subjects is a regular caffeine consumer (up to 2 cups of coffee a day)
  • Subjects agrees to abstain from caffeine the day of each testing session
  • Subjects agrees to abstain from exercise 24 hours prior to each testing visit. 48 hours prior to the testing session, the subject should not do anything new or unaccustomed in the form of exercise and should not increase the intensity of their workouts.

You may not qualify if:

  • Subject has not been participating in regular physical activity and exercise trained for at least 12 months prior to enrollment
  • Subject is diagnosed with any metabolic or chronic disease, or is on prescription medication for the diagnosed metabolic or chronic disease
  • Subject is using, or has used a dietary supplement (other than a multi-vitamin/-mineral, protein powder, or meal replacements) within 6 weeks prior to enrollment. Protein/Meal Replacement Products (MRPs) must not contain any supplements such as creatine, beta-alanine, hydroxyl methlybutyrate (HMB), etc.
  • Subject is in, or has participated in another clinical trial within 8 weeks prior to enrollment
  • Subject has a known allergy or sensitivity to caffeine or other stimulants (determined from health history questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMHB Human Performance Lab

Belton, Texas, 76513, United States

Location

Related Publications (1)

  • Zaragoza J, Tinsley G, Urbina S, Villa K, Santos E, Juaneza A, Tinnin M, Davidson C, Mitmesser S, Zhang Z, Taylor L. Effects of acute caffeine, theanine and tyrosine supplementation on mental and physical performance in athletes. J Int Soc Sports Nutr. 2019 Nov 26;16(1):56. doi: 10.1186/s12970-019-0326-3.

MeSH Terms

Conditions

Mental Fatigue

Interventions

Sugars

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Lemuel W Taylor, PhD

    UMHB Human Performance Lab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Exercise Biochemistry Laboratory

Study Record Dates

First Submitted

December 15, 2016

First Posted

January 12, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations