The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, and Fine Motor Task Performance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clarkson University
- Enrollment
- 30
- Primary Endpoint
- Change in POMS Vigor
Study Overview
Brief Summary
The aim of the research project is to determine the changes in motivation to perform mental and physical tasks, feelings of vigor and fatigue, mental task vigilance and fine motor function after consumption of a commercially available energy product. The purpose of this study is determine whether e+shot, a product containing natural caffeine, will impact mood and performance up to 108 minutes post consumption compared to a sweetened solution containing synthetic caffeine.
Detailed Description
Enrolled participants who are low consumers of caffeine will be administered either a placebo (3mg caffeine), caffeinated placebo (~100mg of caffeine) or e+shot first and then will be crossed over to receive the other two interventions. The study consists of 3 treatment periods of 108 minutes each with a washout period of 48 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Double-blinded placebo controlled
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ages 18-45
- •Body Mass Index (BMI) < 30
- •Profile of Mood Status Short Scale (POMS) score <13 on the energy scale
- •Energy and Fatigue trait scale score <=10
- •Consumption of <200mg of caffeine/day
- •Consumption of <150 servings of polyphenols/month
Exclusion Criteria
- •Subjects taking prescription or over the counter medications (except for oral contraceptives) for a chronic medical condition or recreational drugs will be excluded Chronic medical conditions are any health condition that is expected to last more than 3 months and requires on going medical care such as coronary artery disease, multiple sclerosis, etc..
- •Women who are pregnant or may be trying to become pregnant
- •Women who are breastfeeding
- •People who have been diagnosed with heart conditions and/or hypertension
- •People who have liver disorders
- •People who have sensitivity or allergy to caffeine
- •People who have bipolar disorder
- •People who have iron deficiency
- •People who are allergic to plants of the Asteraceae/Compositae/Daisy family
- •Day of testing
- •Subjects who have had a change of ±2 hours of sleep from their regular sleep time will be re-scheduled.
- •If subjects begin taking a prescription or over the counter medication for an acute condition (i.e. required to take the prescription or over the counter medication for < 3 months) during the study they will be given the option of continuing the study after they are no longer taking the prescription or over the counter medication or dropping out of the study.
- •If subjects are diagnosed with a chronic condition that requires the use of prescription medications for > 3 months after they have started the study they will be eliminated from the study.
- •Resting systolic BP > 180mmHg and diastolic BP > 90mmHg after consuming the caffeine beverage.
Outcomes
Primary Outcomes
Change in POMS Vigor
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
POMS Vigor, Scores range from 0-20 with higher scores indicating improved outcome
Change in POMS Depression
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
POMS Depression Scores range from 0-20 with higher scores indicating worse outcome
Change in POMS Confusion
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minute
POMS Anger Scores range from -4 to 16 with higher scores indicating worse outcome
Change in POMS Fatigue
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
POMS Fatigue Scores range from 0-20with higher scores indicating worse outcome
Change in POMS Anger
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
POMS Anger Scores range from 0-20 with higher scores indicating worse outcome
Change in Heart Rate
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Heart rate- beats per minute
Change in Fine Motor Task Performance
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
9-hole peg test- measured in seconds- The validated nine-hole peg test of finger dexterity was used to measure fine motor control. The 12 cm × 12 cm wooden pegboard contained nine holes and was placed on the desktop in front of the seated participant. There were nine 0.64 cm wide cylindrical pegs, were placed on the desktop outside of the container on the right side of the board and on the left side of the board for when the participant's right hand and left hand were tested, respectively. Participants were instructed to place one peg at a time into the pegboard holes until they were filled, and then remove each peg one at a time onto the desktop as fast as they could, first with their dominant hand and next with their non-dominant hand. Each test was performed twice.
Change in Continuous Performance Task Performance Percent Correct
Time Frame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68, post beverage 3-108 minutes
Continuous Performance Task- Percentage of correct responses Participants monitored a continuous series of letters (A-Z; Tahoma Regular font, size 20 pt) presented on the screen for 1000 ms. Participants were told to respond to the detection of the letter "X" only when it was preceded by the letter "A" by striking the left key on the key pad. The task was scored for percentage of target strings correctly detected, errors of omission (missed targets), average reaction time for correct detections, and the number of false alarms. The task lasted for two minutes and 48 targets were randomly presented
Change in Rapid Visual Input Processing Task Performance Primary Task Reaction Time for Percent Correct
Time Frame: pre beverage- 0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Primary task- reaction time for percent correct
Change in Rapid Visual Input Processing Task Performance Secondary Task Percent Correct
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Secondary task- percentage correct
Change in Rapid Visual Input Processing Task Performance Secondary Task Incorrect Responses
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Secondary task- incorrect responses
Change in POMS Anxiety
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
POMS Anxiety Scores range from 0-20 with higher scores indicating worse outcome
Change in State Mental Energy
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
State Mental Energy- scores range from 0 to 300 with higher scores indicating better outcome
Change in State Physical Energy
Time Frame: pre-beverage-0 minutes, Post beverage 1-30 minutes, Post beverage 2-68 minutes, Post beverage 3 -108 minutes
State Physical Energy- scores range from 0 to 300 with higher scores indicating better outcome
Change in Blood Pressure
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Blood pressure- systolic and diastolic measured in mmHg
Change in Continuous Performance Task Performance Number Incorrect
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
Continuous Performance Task- Number of incorrect responses
Change in Continuous Performance Task Performance Reaction Time Correct Responses
Time Frame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Continuous Performance Task- reaction time for correct responses
Change in Rapid Visual Input Processing Task Performance Secondary Task Percentage Missed Responses
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Secondary task- percentage missed responses
Change in Rapid Visual Input Processing Task Performance Secondary Task Reaction Time for Correct Responses
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Secondary task- reaction time for correct responses
Change in Rapid Visual Input Processing Task Performance- Tertiary Task Percent Missed Responses
Time Frame: pre beverage-0 minute, post beverage-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Tertiary task- percentage missed responses
Change in State Mental Fatigue
Time Frame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
State mental fatigue- scores range from 0 to 300 with higher scores indicating worse outcome
Change in State Physical Fatigue
Time Frame: pre beverage-0, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
State physical fatigue- scores range from 0 to 300 with higher scores indicating worse outcome
Change in Continuous Performance Task Performance Missed Responses
Time Frame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Continuous Performance Task- Percentage of missed responses
Change in Rapid Visual Input Processing Task Performance Primary Task Percentage Correct
Time Frame: pre beverage- 0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Primary task- percentage correct
Change in Rapid Visual Input Processing Task Performance Primary Task Percent Missed
Time Frame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3- 108 minutes
Rapid Visual Input Processing task- Primary task- percentage missed
Change in Rapid Visual Input Processing Task Performance Tertiary Task Percentage Correct Responses
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Tertiary task- percentage correct responses
Change in Rapid Visual Input Processing Task Performance Tertiary Task Number of Incorrect Responses
Time Frame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Tertiary task- number of incorrect responses
Change in Rapid Visual Input Processing Task Performance Primary Task Incorrect Responses
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Primary task- incorrect responses
Change in Rapid Visual Input Processing Task Performance Tertiary Task Reaction Time for Correct Responses
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Rapid Visual Input Processing task- Tertiary task- reaction time for correct responses
Change in Serial Subtraction 3 Task Performance
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Serial subtraction 3- Number of attempts
Change in Serial Subtraction 7 Task Performance
Time Frame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Serial subtraction 7- Number of attempts
Secondary Outcomes
No secondary outcomes reported
Investigators
Ali Boolani
Assistant Professor
Clarkson University