CaffeineNCT03850275
The Effects of e+Shots Energy Beverage on Mental Energy
A study testing Intervention/treatment in people with Caffeine, run by Clarkson University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Intervention/treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2015to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
About this study
Official title: The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, and Fine Motor Task Performance
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.
Read the 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.
- Conditions
- Caffeine
- Being tested
- Intervention/treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention/treatmentDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Intervention/treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in POMS Vigor
POMS Vigor, Scores range from 0-20 with higher scores indicating improved outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre beverage-0 minutes, post beverage 1-30 minutes, post beverage 2-68 minutes, post beverage 3-108 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start26 Sep 2015
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crosover Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarkson University
- Sponsor type
- University, hospital or other
- Collaborators
- Isagenix International LLC
- Responsible party
- Principal investigator, Ali Boolani, Clarkson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850275
- Sponsor's protocol ID
- 16-05
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2018
- Last updated
- 2 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, and Fine Motor Task Performance
- ClinicalTrials.gov ID
- NCT03850275
- Acronym / sponsor ID
- 16-05
- Conditions
- Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clarkson UniversityUniversity, hospital or other
- Collaborators
- Isagenix International LLC
- Study start
- 26 Sep 2015 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 2 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Crosover Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Placebo, then caffeinated placebo, then e+shots | Experimental | Dietary Supplement: Intervention/treatmentParticipants 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 |
| Experimental: Caffeinated placebo, then placebo, then e+shots | Experimental | Dietary Supplement: Intervention/treatmentParticipants 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 |
| Experimental: placebo, then e+shots, then caffeinated placebo | Experimental | Dietary Supplement: Intervention/treatmentParticipants 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. |
| Experimental: caffeinated placebo, then e+shots, then placebo | Experimental | Dietary Supplement: Intervention/treatmentParticipants 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. |
| Experimental: e+shots, then caffeinated placebo, then placebo | Experimental | Dietary Supplement: Intervention/treatmentParticipants 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. |
| Experimental: e+shots, then placebo, then caffeinated placebo | Experimental | Dietary Supplement: Intervention/treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention/treatmentSubjects 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. | Dietary supplement | 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 |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plans to share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention/treatment in people with Caffeine, run by Clarkson University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.