search
Back to results

The Effect of a Caffeine Blend on Reaction Time, Mental Performance and Focus in Athletic Males

Primary Purpose

Mental Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine Blend
Sugar Pill
Sponsored by
University of Mary Hardin-Baylor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Fatigue focused on measuring caffeine, mental performance, reaction time, focus

Eligibility Criteria

18 Years - 25 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria

  • 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.

Subject Exclusion Criteria

  • 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.

Sites / Locations

  • UMHB Human Performance Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar Pill

Caffeine Blend

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed
The secondary 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 physical performance in athletic populations.

Full Information

First Posted
December 15, 2016
Last Updated
January 24, 2017
Sponsor
University of Mary Hardin-Baylor
Collaborators
NBTY, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03019523
Brief Title
The Effect of a Caffeine Blend on Reaction Time, Mental Performance and Focus in Athletic Males
Official Title
Effects Of A Proprietary Supplement On The Acute Responses In Reaction Time, Mental Performance, And Indicators Of Focus In Athletic Populations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mary Hardin-Baylor
Collaborators
NBTY, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Subjects expressing interest in doing the study, were interviewed in the Human Performance Lab (HPL) to determine whether they appear to qualify to participate in the study. Qualifying subjects, were then invited back to the HPL for an entry/familiarization session and be verbally told all of the requirements of the study. During this session, subjects signed Informed Consent Statements and completed personal and medical history questionnaires. Subject were familiarized to the study protocol via a verbal and written explanation outlining the study design. This included describing the testing sessions to the subjects about the tests to be performed including the Makoto testing system (reaction time testing). Subjects practiced several times during this session to eliminate the learning curve of using new equipment. Subjects were also taken through 1 round of the dynamic exercises to ensure ability to complete each exercise as needed. Subjects were then given an appointment time to perform qualifying Makoto testing to achieve greater than or equal to 70% accuracy on 3 towers at a level 7 for three consecutive trails. Following the practice session, subjects recorded all food intake via MyFitnessPal for three days (3-d) prior to baseline testing. Subjects were instructed to refrain from exercise, caffeine, and alcohol the day prior to baseline testing and to consume their normal breakfast the morning of testing. Subjects were given a meal replacement bar in place of lunch, to consume ~2 hours before their testing session. During this time, subjects had body composition and hemodynamic assessments recorded. Two hours after ingestion of meal bar subjects reported back to the HPL and completed a Visual Analog Scale (VAS) questionnaire, a baseline Makoto prior to ingesting their assigned supplement. Thirty minutes after ingestion, Makoto and dynamic exercisers were completed. This involved subjects doing a standardized full body workout in 2 different rounds of exercise. After each round of exercise subjects filled out the VAS and performed Makoto testing. Subject then were instructed to wash-out and were scheduled for their 2nd testing session ~7 days later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue
Keywords
caffeine, mental performance, reaction time, focus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Caffeine Blend
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine Blend
Intervention Description
Taken orally in capsule form
Intervention Type
Other
Intervention Name(s)
Sugar Pill
Intervention Description
Taken orally in capsule form
Primary Outcome Measure Information:
Title
Response to Caffeine on Measures of Reaction Time by Makoto
Description
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.
Time Frame
up to 4 hours
Title
Response to Caffeine on Measures of Mental Performance by Survey in Athletic Populatons
Description
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.
Time Frame
up to 4 hours
Title
Response to Caffeine on Measures of Cognitive Fatigue by Survey in Athletic Populatons
Description
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.
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
Response to Caffeine on Measures of Physical Performance by Comparing the Total Amount of Work Completed
Description
The secondary 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 physical performance in athletic populations.
Time Frame
up to 4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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. Subject Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lemuel W Taylor, PhD
Organizational Affiliation
UMHB Human Performance Lab
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMHB Human Performance Lab
City
Belton
State/Province
Texas
ZIP/Postal Code
76513
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31771598
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of a Caffeine Blend on Reaction Time, Mental Performance and Focus in Athletic Males

We'll reach out to this number within 24 hrs