Clinical trial NCT03850275: The Effects of e+Shots Energy Beverage on Mental Energy
Official title: The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, and Fine Motor Task Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Lead sponsor: Clarkson University
Sponsor class: OTHER
Collaborators: name: Isagenix International LLC
First posted: 2019-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crosover Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in POMS Vigor
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in POMS Fatigue
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in POMS Depression
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in POMS Anxiety
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in POMS Anger
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in POMS Confusion
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minute
measure: Change in Serial Subtraction 3 Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Serial Subtraction 3 Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Serial Subtraction 3 Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Serial Subtraction 7 Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Serial Subtraction 7 Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Serial Subtraction 7 Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Blood Pressure
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Heart Rate
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Fine Motor Task Performance
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in State Mental Energy
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in State Physical Energy
timeFrame: pre-beverage-0 minutes, Post beverage 1-30 minutes, Post beverage 2-68 minutes, Post beverage 3 -108 minutes
measure: Change in State Mental Fatigue
timeFrame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in State Physical Fatigue
timeFrame: pre beverage-0, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
measure: Change in Continuous Performance Task Performance Percent Correct
timeFrame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68, post beverage 3-108 minutes
measure: Change in Continuous Performance Task Performance Number Incorrect
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
measure: Change in Continuous Performance Task Performance Missed Responses
timeFrame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2- 68 minutes, post beverage 3- 108 minutes
measure: Change in Continuous Performance Task Performance Reaction Time Correct Responses
timeFrame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Primary Task Percentage Correct
timeFrame: pre beverage- 0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Primary Task Percent Missed
timeFrame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3- 108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Primary Task Incorrect Responses
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Primary Task Reaction Time for Percent Correct
timeFrame: pre beverage- 0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Secondary Task Percent Correct
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Secondary Task Percentage Missed Responses
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Secondary Task Incorrect Responses
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2- 68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Secondary Task Reaction Time for Correct Responses
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Tertiary Task Percentage Correct Responses
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance- Tertiary Task Percent Missed Responses
timeFrame: pre beverage-0 minute, post beverage-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Tertiary Task Number of Incorrect Responses
timeFrame: pre beverage-0 minutes, post beverage 1- 30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
measure: Change in Rapid Visual Input Processing Task Performance Tertiary Task Reaction Time for Correct Responses
timeFrame: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Secondary outcomes:
Other outcomes:
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Study officials:
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