The Effects of e+Shots Energy Beverage on Mental Energy

Caffeine Clinical Trial

Official title:

The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, and Fine Motor Task Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850275
• Other study ID #: 16-05
• Status: Completed
• Phase: N/A
• Start date: September 26, 2015
• Est. completion date: December 15, 2016

Study information

• Verified date: July 2021
• Source: Clarkson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caffeine

Intervention

Dietary Supplement:
• Intervention/treatment
Subjects received all 3 interventions Placebo ~3mg caffeine Caffeinated placebo ~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clarkson University	Isagenix International LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in POMS Vigor	POMS Vigor, Scores range from 0-20 with higher scores indicating improved outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in POMS Fatigue	POMS Fatigue Scores range from 0-20with higher scores indicating worse outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in POMS Depression	POMS Depression Scores range from 0-20 with higher scores indicating worse outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in POMS Anxiety	POMS Anxiety Scores range from 0-20 with higher scores indicating worse outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in POMS Anger	POMS Anger Scores range from 0-20 with higher scores indicating worse outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in POMS Confusion	POMS Anger Scores range from -4 to 16 with higher scores indicating worse outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minute
Primary	Change in Serial Subtraction 3 Task Performance	Serial subtraction 3- Number of attempts	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Serial Subtraction 3 Task Performance	Serial subtraction 3- Number correct	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Serial Subtraction 3 Task Performance	Serial subtraction 3- Percentage correct	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Serial Subtraction 7 Task Performance	Serial subtraction 7- Number of attempts	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Serial Subtraction 7 Task Performance	Serial subtraction 7- Number correct	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Serial Subtraction 7 Task Performance	Serial subtraction 7- Percentage correct	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Blood Pressure	Blood pressure- systolic and diastolic measured in mmHg	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Heart Rate	Heart rate- beats per minute	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Fine Motor Task Performance	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.	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in State Mental Energy	State Mental Energy- scores range from 0 to 300 with higher scores indicating better outcome	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in State Physical Energy	State Physical Energy- scores range from 0 to 300 with higher scores indicating better outcome	pre-beverage-0 minutes, Post beverage 1-30 minutes, Post beverage 2-68 minutes, Post beverage 3 -108 minutes
Primary	Change in State Mental Fatigue	State mental fatigue- scores range from 0 to 300 with higher scores indicating worse outcome	pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in State Physical Fatigue	State physical fatigue- scores range from 0 to 300 with higher scores indicating worse outcome	pre beverage-0, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
Primary	Change in Continuous Performance Task Performance Percent Correct	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	pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68, post beverage 3-108 minutes
Primary	Change in Continuous Performance Task Performance Number Incorrect	Continuous Performance Task- Number of incorrect responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
Primary	Change in Continuous Performance Task Performance Missed Responses	Continuous Performance Task- Percentage of missed responses	pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
Primary	Change in Continuous Performance Task Performance Reaction Time Correct Responses	Continuous Performance Task- reaction time for correct responses	pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Primary Task Percentage Correct	Rapid Visual Input Processing task- Primary task- percentage correct	pre beverage- 0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Primary Task Percent Missed	Rapid Visual Input Processing task- Primary task- percentage missed	pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3- 108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Primary Task Incorrect Responses	Rapid Visual Input Processing task- Primary task- incorrect responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Primary Task Reaction Time for Percent Correct	Rapid Visual Input Processing task- Primary task- reaction time for percent correct	pre beverage- 0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Secondary Task Percent Correct	Rapid Visual Input Processing task- Secondary task- percentage correct	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Secondary Task Percentage Missed Responses	Rapid Visual Input Processing task- Secondary task- percentage missed responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Secondary Task Incorrect Responses	Rapid Visual Input Processing task- Secondary task- incorrect responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Secondary Task Reaction Time for Correct Responses	Rapid Visual Input Processing task- Secondary task- reaction time for correct responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Tertiary Task Percentage Correct Responses	Rapid Visual Input Processing task- Tertiary task- percentage correct responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance- Tertiary Task Percent Missed Responses	Rapid Visual Input Processing task- Tertiary task- percentage missed responses	pre beverage-0 minute, post beverage-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Tertiary Task Number of Incorrect Responses	Rapid Visual Input Processing task- Tertiary task- number of incorrect responses	pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Primary	Change in Rapid Visual Input Processing Task Performance Tertiary Task Reaction Time for Correct Responses	Rapid Visual Input Processing task- Tertiary task- reaction time for correct responses	pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes