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Trial record 3 of 7 for:    isagenix

The Effects of e+Shots Energy Beverage on Mental Energy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850275
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Isagenix International LLC
Information provided by (Responsible Party):
Ali Boolani, Clarkson University

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 180 minutes post consumption compared to a sweetened solution containing synthetic caffeine.

Condition or disease Intervention/treatment Phase
Caffeine Dietary Supplement: E+shots Dietary Supplement: Caffeinated placebo Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blinded placebo controlled
Primary Purpose: Treatment
Official Title: The Effects of E+Shots Energy Beverage on Mood, Cognitive Function, Heart Rate, Blood Pressure, Cortisol and Fine Motor Task Performance
Actual Study Start Date : September 26, 2015
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Sham Comparator: Placebo
<3mg of caffeine
Dietary Supplement: Placebo
~3mg caffeine

Active Comparator: Caffeinated placebo
~100mg caffeine
Dietary Supplement: Caffeinated placebo
~100mg of synthetic caffeine

Experimental: E+shots
~100mg caffeine + adaptogens
Dietary Supplement: 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 Outcome Measures :
  1. Change in POMS Energy [ Time Frame: 30, 90, 120, 150 minutes ]
    POMS Energy, Scores range from 0-20 with higher scores indicating improved outcome

  2. Change in POMS Fatigue [ Time Frame: 30, 90, 120, 150 minutes ]
    POMS Fatigue Scores range from 0-20with higher scores indicating worse outcome

  3. Change in POMS Depression [ Time Frame: 30, 90, 120, 150 minutes ]
    POMS Depression Scores range from 0-20 with higher scores indicating worse outcome

  4. Change in POMS Anxiety [ Time Frame: 30, 90, 120, 150 minutes ]
    POMS Anxiety Scores range from 0-20 with higher scores indicating worse outcome

  5. Change in POMS Anger [ Time Frame: 30, 90, 120, 150 minutes ]
    POMS Anger Scores range from 0-20 with higher scores indicating worse outcome

  6. Change in POMS Confusion [ Time Frame: 30, 90, 120, 150 minutes ]
    POMS Anger Scores range from -4 to 16 with higher scores indicating worse outcome

  7. Change in Serial Subtraction 3 Task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Serial subtraction 3- Number of attempts

  8. Change in Serial Subtraction 3 Task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Serial subtraction 3- Number correct

  9. Change in Serial Subtraction 3 Task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Serial subtraction 3- Percentage correct

  10. Change in Serial Subtraction 7 Task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Serial subtraction 7- Number of attempts

  11. Change in Serial Subtraction 7 Task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Serial subtraction 7- Number correct

  12. Change in Serial Subtraction 7 Task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Serial subtraction 7- Percentage correct

  13. Change in blood pressure [ Time Frame: 30, 90, 120, 150 minutes ]
    Blood pressure- systolic and diastolic measured in mmHg

  14. Change in heart rate [ Time Frame: 30, 90, 120, 150 minutes ]
    Heart rate- beats per minute

  15. Change in fine motor task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    9-hole peg test- measured in seconds

  16. Change in cortisol [ Time Frame: 0 and 180 minutes ]
    Cortisol measured in nano moles

  17. Change in state mental energy [ Time Frame: 30, 90, 120, 150 minutes ]
    State Mental Energy- scores range from 0 to 300 with higher scores indicating better outcome

  18. Change in state physical energy [ Time Frame: 30, 90, 120, 150 minutes ]
    State Physical Energy- scores range from 0 to 300 with higher scores indicating better outcome

  19. Change in state mental fatigue [ Time Frame: 30, 90, 120, 150 minutes ]
    State mental fatigue- scores range from 0 to 300 with higher scores indicating worse outcome

  20. Change in state physical fatigue [ Time Frame: 30, 90, 120, 150 minutes ]
    State physical fatigue- scores range from 0 to 300 with higher scores indicating worse outcome

  21. Change in continuous performance task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Continuous Performance Task- Percentage of correct responses

  22. Change in continuous performance task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Continuous Performance Task- Number of incorrect responses

  23. Change in continuous performance task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Continuous Performance Task- Percentage of missed responses

  24. Change in continuous performance task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Continuous Performance Task- reaction time for correct responses

  25. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Primary task- percentage correct

  26. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Primary task- percentage missed

  27. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Primary task- incorrect responses

  28. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Primary task- reaction time for percent correct

  29. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Secondary task- percentage correct

  30. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Secondary task- percentage missed responses

  31. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Secondary task- incorrect responses

  32. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Secondary task- reaction time for correct responses

  33. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Tertiary task- percentage correct responses

  34. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Tertiary task- percentage missed responses

  35. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Tertiary task- number of incorrect responses

  36. Change in rapid visual input processing task performance [ Time Frame: 30, 90, 120, 150 minutes ]
    Rapid Visual Input Processing task- Tertiary task- reaction time for correct responses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Study Documents (Full-Text)

Documents provided by Ali Boolani, Clarkson University:

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Responsible Party: Ali Boolani, Assistant Professor, Clarkson University
ClinicalTrials.gov Identifier: NCT03850275    
Other Study ID Numbers: 16-05
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share individual participant data with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents