The Effects of e+Shots Energy Beverage on Mental Energy

NCT03850275 | Completed Results

• 1 other identifier: 16-05
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caffeine

Outcome Measures

Primary Outcomes (35)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (6)

Experimental: Placebo, then caffeinated placebo, then e+shots

EXPERIMENTAL

Participants received placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes

Dietary Supplement: Intervention/treatment

Experimental: Caffeinated placebo, then placebo, then e+shots

EXPERIMENTAL

Participants received caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the e+shot and were tested for 108 minutes

Dietary Supplement: Intervention/treatment

Experimental: placebo, then e+shots, then caffeinated placebo

EXPERIMENTAL

Participants received placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received e+shots and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes.

Dietary Supplement: Intervention/treatment

Experimental: caffeinated placebo, then e+shots, then placebo

EXPERIMENTAL

Participants received caffeinated placebo and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the e+shots and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes.

Dietary Supplement: Intervention/treatment

Experimental: e+shots, then caffeinated placebo, then placebo

EXPERIMENTAL

Participants received e+shots and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the caffeinated placebo and tested for 108 minutes. After another 48 hour washout period they received the placebo and were tested for 108 minutes.

Dietary Supplement: Intervention/treatment

Experimental: e+shots, then placebo, then caffeinated placebo

EXPERIMENTAL

Participants received e+shots and were tested for 108 minutes after consumption. After a 48 hour washout period, they received the placebo and tested for 108 minutes. After another 48 hour washout period they received the caffeinated placebo and were tested for 108 minutes.

Dietary Supplement: Intervention/treatment

Interventions

Intervention/treatment DIETARY_SUPPLEMENT

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.

Experimental: Caffeinated placebo, then placebo, then e+shots; Experimental: Placebo, then caffeinated placebo, then e+shots; Experimental: caffeinated placebo, then e+shots, then placebo; Experimental: e+shots, then caffeinated placebo, then placebo; Experimental: e+shots, then placebo, then caffeinated placebo; Experimental: placebo, then e+shots, then caffeinated placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clarkson University: lead
• Isagenix International LLC: collaborator

MeSH Terms

Interventions

Methods; Therapeutics

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

There were technical problems with the Continuous Performance Task and Rapid Visual Input Processing task and not all data were interpretable.

Results Point of Contact

• Title: Ali Boolani
• Organization: Clarkson University

aboolani@clarkson.edu

3152681663

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded placebo controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Crosover Assignment

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: February 21, 2019
• Study Start: September 26, 2015
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: August 2, 2021
• Results First Posted: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share