The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, and Fine Motor Task Performance
Phase: NA
Conditions: Caffeine
Sponsor: Clarkson University

September 27, 2017 
 
 
The effects of E+shots on mood, cognitive function, heart rate, blood pressure, cortisol and fine motor task 
performance 
NCT #16-05 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

September 27, 2017 
 
Design: This is a double blinded cross-over experiment with repeated measures on treatment (25mg caffeine 
vs 100mg caffeine vs e+shots) and Time (Time 1 (pre-beverage), Time 2, Time 3, Time 4). Previous night’s sleep 
and occupation may be used as a co-variate in the statistical analysis. 
 
Procedure: 
Screening day:  
• 
Potential subjects will complete an initial online screening using questionnaires that will be posted on 
surveymonkey.com. The appendices listed below are the questionnaires that are posted in the 
survey. 
• 
The survey may be accessed through the tiny URL, QR code, or through a link that will be provided by 
the researcher.  
o 
Appendix G- A demographic and medical history questionnaire 
§ 
As seen in the exclusion criteria all subjects who use prescription or over the 
counter medications for chronic medical conditions will not be allowed to 
participate in the study, with the exception of people taking oral contraceptives. 
§ 
Subjects who are taking a prescription or over the counter medication for an acute 
health condition may be asked to participate in the study after they are no longer 
taking the medication or they will be given the option to drop out of the study. 
o 
Appendix H- Profile of Mood Survey (POMS) brief form 
§ 
We will calculate the energy score of the POMS.  
§ 
If the energy score is >=13 then the potential subject will be eliminated from the 
study 
o 
Appendix I- Caffeine consumption questionnaire 
§ 
Using the data from this survey subjects who consume >=200mg of caffeine per day 
will be eliminated from this study 
o 
Appendix J- Food frequency questionnaire 
§ 
Using the data from this survey subjects who consume >=150 servings of 
polyphenols per month will be eliminated from the study 
o 
Appendix K- Mental and Physical State and Trait Energy and Fatigue Scales (see appendix R 
for approval to use questionnaire) 
§ 
The objective of this scale is to control of cognitive bias by asking questions 
regarding use of prescription drugs and using a different energy and fatigue scale to 
measure energy levels.  
§ 
A score of >10 on the energy scale will eliminate the potential subject 
§ 
This scale also measures physical and mental activity levels which will be used in the 
statistical analysis as covariates 
o 
Appendix L- Pittsburgh sleep quality index 
§ 
This survey will be used to measure sleep time and sleep quality of potential 
subjects.  
§ 
Sleep will be used to determine eligibility on day of testing 
§ 
Sleep quality will be used as a covariate in the statistical analysis 
• 
After completion of survey, a research assistant will verify that the subject is eligible for the study and 
will contact them via the email that is provided by the subject.  
Researchers will review the results of all of these questionnaires to confirm if a potential subject met the criteria or 
did not. Potential subjects who met the criteria will be asked via e-mail to schedule a mutually convenient date for 
“familiarization day” (see below) to confirm eligibility, perform the second informed consent, and begin 
participating in the study (appendix S). Potential subjects who did not meet the criteria will be notified and 
thanked for their time via e-mail (appendix T). 
 
Day 1: Familiarization day 
To reduce experimental error that may occur due to learning effect, subjects will be asked to come in for 
approximately 40 minutes to familiarize themselves with the protocol. This time will also be used to confirm their 

September 27, 2017 
 
eligibility by confirming the accuracy of the information entered in the initial screening questionnaires, obtain 
informed consent and begin the procedure. The following will be the procedure for the day: 
• 
We will measure subjects’ height and weight using a stadiometer and scale, as well as BP. We will 
eliminate subjects who have a BMI >30.0 and resting systolic BP >140mmHg or resting diastolic BP 
>90mmHg. 
• 
Subjects will then go through a test battery of: 
o 
Computerized cognitive battery (see appendix V for description): 
§ 
Serial subtraction of the number three 
 
 
 
2 minutes 
§ 
Serial subtraction of the number seven 
 
 
 
2 minutes 
§ 
Continuous performance test (CPT) 
 
 
 
5 minutes 
§ 
Bakan rapid visual processing task  
 
 
 
16 minutes 
o 
Self-reported measures (see Appendix N, O, H) 
§ 
Motivation to perform cognitive tasks 
 
 
 
1 minute 
§ 
Visual analog scales of mental energy and fatigue 
 
 
1 minute 
§ 
Profile of Mood State fatigue and vigor scales 
 
 
3 minutes 
o 
Physiological measures 
§ 
Resting heart rate and blood pressure 
 
 
 
1 minute 
o 
Fine motor skills 
§ 
9-hole peg test 
 
 
 
 
 
 
5 minutes 
 
 
 
Total time 
 
 
 
 
 
 
36 minutes 
Subjects who are excluded or choose to drop out on this date will not receive the $5 compensation. 
 
Days 2-4 
Testing days 2-4 will be similar except subjects will consume a different beverage daily (list the 3 different 
beverages). To reduce bias, the days that subjects will consume a certain beverage will be randomized using a 
randomizing software on randomizer.org. All beverages are labeled as products, A, B or C and are blinded for the 
researcher. Information regarding all beverages is listed in Table 1. 
On each day subjects will complete the following procedure: 
Subjects will complete a pre-screening questionnaire on each day. The questionnaire will contain the following 
surveys 
• 
Appendix M- 24 hour drug/medicine/supplement recall 
o 
This survey asks for a 24-hour prescription medication, over the counter medication, and 
supplement recall. Because of the potential for cognitive bias (as described above) we are asking 
the subjects for the names of any medications they may be taking. In our past studies there were 
a few subjects that initially reported that they were not taking any prescription or over the 
counter medications (either for a chronic or acute health condition) however, during the daily 
testing procedures when we asked these subjects specifically what medications they were taking 
they listed certain medications.  By asking specifically what medications the subjects are taking 
we are hoping to reduce the risk of cognitive bias and appropriately eliminate subjects who are 
taking prescription or over the counter medications while they are in the study.  
§ 
The survey asks if subjects are taking an oral contraceptive and specifically what the 
name of the oral contraceptive is. The information on the specific type of oral 
contraceptive is needed as certain oral contraceptives have an impact on mood while 
others do not (Kahn & Halbriech, 2005). 
o 
We are also asking for caffeine intake and time of intake. To control for cognitive bias we are 
asking for time of intake. 
• 
Appendix N- Sleep questionnaire 
o 
This survey will be used to determine the amount of sleep the subject had the night before. 
o 
This survey will serve two purposes 
§ 
If subjects had > or < ±2 hours of sleep from their normal sleep then they will be 
rescheduled. Their normal sleep will be determined using Appendix L. Their normal 
sleep will be given to the researcher in charge of collecting data prior to subject’s arrival.  

September 27, 2017 
 
§ 
If the subject is eligible for the study, the sleep may be used as a covariate in the data 
analysis. 
• 
Appendix Q- What I ate today 
o 
This survey will be used to determine what the subject ate the day of the testing 
o 
The information may be used during data analysis to estimate methyxanthine intake 
 
After subjects have been pre-screened for the day, the research assistant will collect saliva using the drool down 
method. To collect data using the drool down method subjects must collect saliva in their mouth and let it drool 
down through a straw into a 15mL saliva collection tube. After ~2mL of saliva has been collected, saliva will be 
stored in a chest filled with ice, prior to transportation to a freezer that is set at -80F.  
After saliva collection, subjects will go through the following mental energy test battery (see table 2). Consumption 
of beverages and subsequent mental energy test batteries will be administered as outlined in table 2.  
Dependent Variables  
1) Computerized cognitive battery: 
a. Serial subtraction of the number three  
 
 
2 minutes 
b. Serial subtraction of the number seven  
 
 
2 minutes 
c. 
Continuous performance test (CPT) 
 
 
 
5 minutes 
d. Bakan rapid visual processing task 
 
 
 
16 minutes 
2) Self-reported measures  
a. Motivation to perform cognitive tasks (Appendix N) 
 
1 minute 
b. Visual analog scales of mental energy and fatigue (Appendix O) 
1 minute 
c. 
POMS (Appendix H)  
 
 
 
 
3 minutes 
3) Physiological measures 
a. Resting heart rate and blood pressure  
 
 
1 minute 
4) Fine motor skills 
a. 9-hole peg test 
 
 
 
 
 
5 minutes 
 
Total time 
 
 
 
 
 
 
 
36 minutes 
 
 
The 9-hole peg test is used to measure finger dexterity. The test is administered by asking the client to take the pegs 
from a container, one by one, and place them into the holes on the board, as quickly as possible. Participants must 
then remove the pegs from the holes, one by one, and replace them back into the container.  
 
After completion of the mental test batteries and procedure outlined in Table 2, subjects saliva will be collected 
again using the drool down method.  
 
 
 
Table 1 
Ingredient Name                 
Current E-shot  
Placebo w/ 
Caffeine 
Placebo w/o 
Caffeine 
Water 
4oz  
4oz 
4oz 
LERA Herbal Extract Complex  
Proprietary 
0 
0 
Green Tea (Camellia sinensis) Leaf Extract (50% 
Caffeine) 
Proprietary 
0 
0 
Yerba Mate Extract (25% Caffeine) 
Proprietary 
0 
0 
D-Ribose 
25.000 mg 
0 
0 

September 27, 2017 
 
 
Table 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Synthetic Caffeine  
0.000 
100.000mg 
0 
Apple Juice Concentrate 70 Brix 
Trace amounts  
Trace amounts   
Trace amounts  
Glycerin (vegetable source) 
Trace amounts   
Trace amounts  
Trace amounts  
Stevia (Stevia rebaudiana) Leaf Extract, 97% 
Trace amounts  
Trace amounts  
Trace amounts  
Pomegranate Juice Concentrate ME-3605 
Trace amounts  
Trace amounts  
Trace amounts  
Masking Flavor Nat ME-1748 
Trace amounts  
Trace amounts   
Trace amounts   
Pomegranate-Berry Flavor Nat ME-2569 
Trace amounts   
Trace amounts   
Trace amounts  
Mint Flavor Nat WONF ME-2759 
Trace amounts   
Trace amounts   
Trace amounts   
Sodium Citrate 
Trace amounts   
Trace amounts   
Trace amounts   
Malic Acid 
Trace amounts   
Trace amounts   
Trace amounts   
Potassium Sorbate 
Trace amounts   
Trace amounts   
Trace amounts   
  
  
  
  
Time (minutes) 
Event 
Test Phase 
0 – 36 
Test battery 
Trial 1 
36-66 
Beverage then seated rest 
 
66-102 
Test battery 
Trial 2 
102-112 
Rest 
 
112-148 
Test battery 
Trial 3 
148-158 
Rest 
 
158-194 
Test battery 
Trial 4 

September 27, 2017 
 
 
 
Analysis of outcomes: 
 
Hypothesis will be tested using a two factor (3 beverages x 4 times) repeated measures ANCOVA on change 
scores (Times 4, 3 and 2 minus Time 1 are the 4 Times). The primary interest will be whether there is a 
statistically significant main effect for time or interaction. Focused contrasts between specific time points as 
follow up tests. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

September 27, 2017 
 
 
 
- Informed consent for online screening 
 
Clarkson University 
Documentation of Informed Consent to Participate in Research 
 
I agree to answer online questions about my demographics, medical and physical activity history, caffeine 
consumption, and recent dietary patterns including alcohol consumption truthfully. It takes about 15 minutes to 
answer the questions.  
 
Purpose. The purpose of me providing this information is to determine whether or not I am eligible to participate in 
a research study titled “Effect of Isagenix e-shot energy beverage on mental energy”. 
 
Project Title: Effects of Isagenix e-shot energy beverage on mental energy 
Researcher(s): Ali Boolani, Costel Darie 
Institutional Review Board (IRB) approval number: 16-34.1 
Approval valid until: 9/26/2018 
 
You have been asked to be a part of the research described here. Participation is voluntary. 
 
The purpose of this study: The purpose of this study is to determine the impact of natural and synthetic caffeine 
on mood and cognitive function. 
 
What to expect:          
I will complete a series of questionnaires that will determine my eligibility for this study. The surveys that I will be 
completing will include a list of demographic, medical and physical activity history, mood, caffeine consumption 
and recent dietary patterns including alcohol consumption. If I feel tired at any time I may stop taking the surveys. I 
cannot exit the surveys and then re-take them but I can stop and start them at any time. If I feel uncomfortable 
taking any of these surveys I may stop the surveys and drop out of this study at any point. If you have any 
questions about this research you may contact 
Ali Boolani at aboolani@clarkson.edu  
 
Risks and discomforts to you if you take part in this study:  
It is possible that you may experience some discomfort and fatigue from filling out the survey. You may stop the 
survey at any time. Your information will be kept private on a password protected computer. If you feel 
uncomfortable with any of the information that is asked during this study you may drop out at any time. 
 
The benefits to you if you take part in this study:  
There are no direct benefits to you from completing this online survey. 
 
What will you receive for taking part in this study:  
You will receive no compensation for completing this survey. However, if you qualify for the study you may be 
eligible to receive up to $175. 
 
What will happen to the information collected in this study: The information collected will be kept confidential as 
much as is permitted by law. Please note that Internet communications are insecure and there is a limit to the 
confidentiality that can be guaranteed due to the technology itself. If you are not comfortable with the level of 
confidentiality provided by the Internet, please feel free to print out a copy of the survey, fill it out by hand, and 
mail it to me at the address given below, with no return address on the envelope. Ali Boolani, Department of 
Physical Therapy, Box 5880, 8 Clarkson Avenue, Potsdam, NY, 13699. You should include your name and a valid 
email address in the survey for us to contact you 
 
What rights do you have when you take part in this study: Participation in this research is voluntary. Deciding not 

September 27, 2017 
 
to take part, or to stop being a part of this research will result in no penalty, fine or loss of benefits that you 
otherwise have a right to. If you have questions about your rights as a research subject or if you wish to report any 
harm, injury, risk or other concern, please contact Dr. Johndan Johnson-Eilola, Chair of the Clarkson University 
Institutional Review Board (IRB) for human subjects research: (315) 268-6488 or johndan@clarkson.edu  
 
. 
 
 
Conflict of Interest: This study is sponsored by the Isagenix corporation 
 
Informed Consent: Please acknowledge reading this consent form by providing your name and email in the text box 
below. By entering your name and email you are consenting to the use of your information for the purposes of this 
study. Since there is no simple way to sign an online form you are being asked to enter your information and click 
submit. By providing your name and clicking submit you are attesting to the fact that you are between the ages of 
18-45: 
 
 
Name: 
Contact email: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

September 27, 2017 
 
In-person Informed consent 
 
Clarkson University 
Documentation of Informed Consent to Participate in Research 
 
Project Title: Effects of Isagenix e-shot energy beverage on mental energy 
Researcher: Ali Boolani 
Institutional Review Board (IRB) approval number: 16.34.1 
Approval valid until: 09/26/2018 
 
You have been asked to be a part of the research described here. Participation is voluntary. 
 
The purpose of this study: The primary purpose of the research is to learn the extent to which synthetic and 
natural caffeine influence measures of mental energy. 
 
What to expect: If you volunteer, your participation will involve a total time commitment of about 17.5 hours. You 
will be required to visit the laboratory in room 256 in Clarkson Hall 4 separate days. Testing on days 2-4 will take 
approximately 3 hours and 20 minutes each day. You will do the following: 
 
1. You will go to the lab on testing day 1 and complete questionnaires and practice the measures of mental 
energy. This will take about 30 minutes. 
2. On testing days 2-4 you will go to the lab at my agreed upon time and location. You will report on how 
you slept the night before and recreational and/or prescription drug use. You will provide saliva and 
complete a series of questionnaires, cognitive tests, fine motor tasks and my heart rate and blood 
pressure will be monitored. You will consume the beverage provided to you. You will rest for 30 minutes. 
Then over the next 140 minutes you will complete questionnaires, cognitive tests, fine motor tasks and 
my heart rate and blood pressure will be monitored four more times. Also, you will provide a two 
milliliters (about ½ of a teaspoon) of saliva, into a coded test tube (Your name will not be on the test tube) 
two times each day (at the beginning and end of testing). These coded test tubes will be frozen, analyzed 
in labs at Clarkson for cortisol and caffeine. Any remaining saliva will be thrown away. 
Risks and discomforts to you if you take part in this study: It is possible that you will experience minor stomach 
discomfort and an elevated heart rate after consuming the beverage. The only minor risks include possible 
stomach discomfort and the risk is being reduced by excluding people with allergies or gastrointestinal problems. 
We are minimizing the risk by checking for heart rate every 30 minutes. If you feel uncomfortable answering any of 
the questions that are asked in this study you may drop out of the study at any time.  
 
The benefits to you if you take part in this study: You will receive no direct benefit by participating. New 
knowledge about the influence of acute cocoa consumption on mental energy will be obtained and shared with 
the scientific community. 
 
What will you receive for taking part in this study: You will receive monetary compensation in the amount of $5 
for completing day 1, $10 for completing day 2, $10 for completing day 3 and $150 for completing day 4 for a total 
of $175. 
 
What will happen to the information collected in this study: No individually-identifiable information about you, or 
provided by you during the research, will be shared with others without your written permission, except if 
necessary to protect your rights or welfare (for example, if you are injured and need emergency care), or if 
required by policy of Clarkson University’s Research Participant Payment Policy. 
 
The two consent forms that contain my name and that you sign will be kept in a location separate from the 
information that will be obtained from you during this study. To safeguard your identity, you will give the 

September 27, 2017 
 
researcher a 5-digit code that the researcher will use on all forms. This code will not appear on the consent forms. 
If selected to qualify, your 5-digit number will be given to you on a notecard to type and use for the rest of the 
protocol. 
 
My identity will not be revealed in any publication of the results of this research. The individually-identifiable 
results of your participation will be confidential. A copy of your test results and the study results will be made 
available to you if you request it. You will need to remember and provide your 5-digit code. To receive the 
payment you will have to provide your name and address on a sheet of paper that will be given to the Department 
of Physical Therapy. You can participate without payment. 
 
The Principal Investigator, Dr. Ali Boolani, or the research assistant will be happy to answer any further questions 
about the research, now or during the course of the project. Ali Boolani can be reached by telephone in his office 
(315-268-1663) or on his cell phone (504-319-5828) or by email (aboolani@clarkson.edu). 
 
 
What rights do you have when you take part in this study: Participation in this research is voluntary. Deciding not 
to take part, or to stop being a part of this research will result in no penalty, fine or loss of benefits that you 
otherwise have a right to. If you have questions about your rights as a research subject or if you wish to report any 
harm, injury, risk or other concern, please contact Dr. Johndan Johnson-Eilola, Chair of the Clarkson University 
Institutional Review Board (IRB) for human subjects research: (315) 268-6488 or johndan@clarkson.edu  
 
Conflict of Interest: The researchers have no financial interest in performing this study. 
 
Informed Consent: Please sign here to show you have had the purpose of this research explained and you have 
been informed of what to expect and your rights. You should have all your questions answered to your 
satisfaction. Your signature shows that you agree to take part in this research. By signing below you also attest that 
you are 
• 
Not taking any prescription for chronic conditions  
• 
Are between the ages of 18-45. 
• 
Not a woman who is pregnant, or is trying to become pregnant 
• 
Not breastfeeding 
• 
Not diagnosed with a heart conditions, high blood pressure, live disorder, bipolar disorder or iron 
deficiency.  
• 
Not allergic or sensitive to caffeine.  
If you have any of the preceding conditions you may be putting your health at risk by participating in this study. 
You will be given a copy of this consent form to keep for your records. 
 
Signature of volunteer:  
   Date:  
 
Signature of researcher 
obtaining informed consent:  
   Date:  
 
In addition to the Primary Investigator, listed above, the following people have been authorized to obtain 
Informed Consent: