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Completed

NCT Number: NCT03850275

The Effects of e+Shots Energy Beverage on Mental Energy

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.

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Key information

Conditions

Caffeine

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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 correct

  9. 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- Percentage correct

  10. 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

  11. 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 correct

  12. 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- Percentage correct

  13. 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

  14. 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

  15. 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.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

Sponsors and collaborators

Lead sponsor

Clarkson University

Other

Collaborators

  • Isagenix International LLC

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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