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Evaluate the Effectiveness and Safety of the Alpinia Galanga Formulation, Theacrine Formulation, and Caffeine Formulation on Fatigue, Mental Acuity, and Cognitive Health

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: NCT05170113
Recruitment Status : Completed
First Posted : December 27, 2021
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess the effectiveness and safety of the Alpinia galanga formulation, Theacrine formulation, and Caffeine formulation on fatigue, mental acuity, and cognitive health among overall healthy participants

Condition or disease Intervention/treatment Phase
Fatigue Dietary Supplement: Alpinia galanga formulation Dietary Supplement: Theacrine formulation Dietary Supplement: Caffeine formulation Dietary Supplement: Placebo Not Applicable

Detailed Description:

This is a 4-arm pilot, double-blind, randomized, placebo-controlled, parallel design study. A total of 80 subjects (20 per treatment arm) will be enrolled in a randomly assigned sequence to receive either the Alpinia galanga formulation, Theacrine formulation, Caffeine formulation, or placebo in individuals and admit to experiencing occasional fatigue (tiredness) and would like more energy.

Participants will need to complete assessments and questionnaires.

The primary objective is the evaluation of the change in the response to the VAS-F (Visual Analogue Scale to Evaluate Fatigue Severity) relative to baseline. The secondary objective is the evaluation of the change in the responses to the BCAT-SF (Brief Cognitive Health Assessment Short Form), LSEQ (Leeds Sleep Evaluation Questionnaires), and SF-36 Health Survey (Short Form 36) compared to baseline.

Safety and tolerability will be evaluated through the receipt of documentation and responses from the telephone contacts/ emails per protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: A Pilot, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Effectiveness and Safety of an Alpinia Galanga Formulation, Theacrine Formulation, and Caffeine Formulation on Fatigue, Mental Acuity, and Cognitive Health Among Overall Healthy Participants
Actual Study Start Date : November 2, 2021
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Fatigue

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Alpinia galanga formulation
Alpinia galanga formulation capsule: Take one (1) capsule once daily at noon with 8 oz. (240 ml) of water for a 14-day dosing period
 Dietary Supplement: Alpinia galanga formulation
Alpinia galanga formulation capsule- 1 capsule daily
Active Comparator: Theacrine formulation
Theacrine formulation capsule: Take one (1) capsule once daily at noon with 8 oz. (240 ml) of water for a 14-day dosing period
 Dietary Supplement: Theacrine formulation
Theacrine formulation capsule- 1 capsule daily
Active Comparator: Caffeine formulation.
Caffeine formulation capsule: Take one (1) capsules once daily at noon with 8 oz.(240 ml) of water for a 14-day dosing period
 Dietary Supplement: Caffeine formulation
Caffeine formulation capsule- I capsule daily
Placebo Comparator: Placebo
Placebo capsule: Take one (1) capsule once daily at noon with 8 oz. (240 ml) of water for a 14-day dosing period
 Dietary Supplement: Placebo
Placebo capsule- 1 capsule daily


Outcome Measures
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Primary Outcome Measures :
  1. VAS-F (Visual Analogue Scale to Evaluate Fatigue Severity) [ Time Frame: 14 Days ]
    Assessment of the mean change in the results of the VAS-F survey from baseline. This consists of 18 items relating to the subjective experience of fatigue with a Fatigue subscale and Energy subscale. The scores can range from 0-10 and the lower the score indicates a better outcome.


Secondary Outcome Measures :
  1. BCAT-SF (Brief Cognitive Health Assessment Short Form) [ Time Frame: 14 Days ]
    Assessment of the mean change in the results of the Brief Cognitive Assessment Tool (BCAT-SF) survey from baseline. It is a 6-item instrument with a score range of 0-21. The higher the score indicates a better outcome.


Other Outcome Measures:
  1. LSEQ (Leeds Sleep Evaluation Questionnaires) [ Time Frame: 14 Days ]
    Assessment of the mean change in the results of the Leeds Sleep Evaluation Questionnaire (LSEQ) survey from baseline. This questionnaire consists of ten self-rating questions related to four consecutive aspects of sleep (getting to sleep. quality of sleep, awakening from sleep and behavior following sleep). The total LSEQ socre can range from 0-100. The higher the total global LSEQ score indicates a better outcome.

  2. SF-36 Health Survey (Short Form 36) [ Time Frame: 14 Days ]
    Assessment of the mean change in the results of the Short Form-36 (SF-36) Health survey from baseline. This is a 36-item questionnaire that coversa eight domains including physiccal functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. The socres from each domain can range from 0-100, The higher the scores for each domain indicates a better outcome.


Eligibility Criteria
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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:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ambulatory, male or female, 30-70 years of age
  2. A body mass index (BMI) of 18.5 - 34.9
  3. Admits to experiencing occasional fatigue (tiredness) and would like more energy
  4. Has consumed no more than two cups of coffee or caffeinated beverage per day for seven or more days before Screening/baseline
  5. Has personal access to and able to operate a smartphone, tablet, or computer with enough memory to accommodate additional application(s) and reliable internet service
  6. Able to complete tests online with a computer
  7. Able to print out and return documents by scan, email, or mail
  8. Has regular daytime work hours or shifts, if employed (regular shift excludes night shift workers and those with rotating shifts)
  9. Generally healthy and having no significant difficulty with digestion or absorption of food
  10. Able to complete an Activity Log and Study Product Log daily
  11. Has been generally weight stable for the past six months (give or take 6 lbs.)
  12. Willing and able to give written informed consent
  13. Clearly understands the procedures and study requirements
  14. Willing and able to comply with all study procedures, as per protocol
  15. Able to communicate, including reading, in English
  16. Has not taken any nutritional supplements that may contain any of the components of the study products including Alpinia galanga, Theacrine or Caffeine for a minimum of 14 days before Screening/baseline

Exclusion Criteria:

  1. Not having the basic skills needed to operate a smartphone, tablet, or computer
  2. Unwilling to abstain from consuming more than two cups of coffee or caffeinated beverage/food per day and no caffeinated beverage/food after 10 am daily for the duration of the study
  3. Having smoked any cigarette, electronic cigarette, cigar, or pipe, or used marijuana, any recreational drug or cannabidiol (CBD) in the past 30 days
  4. Donated blood within the 30 days prior to Screening/baseline
  5. Having participated in another study within 30 days before Screening/baseline
  6. Being pregnant or planning on becoming pregnant during study participation; or breast feeding
  7. History of allergy or sensitivity to any component of the study products
  8. Currently taking or having taken within the 30 days prior to Screening/baseline any medication(s) or supplement(s) which may have a stimulant effect in the judgment of the Study Investigator/Sub-investigator

  9. Having been diagnosed, received medical treatment, or taking medication daily for any of the following medical condition(s):

    • Chronic fatigue syndrome
    • Fibromyalgia
    • Sleep disorder, including sleep apnea

  10. Presence of active or recurring clinically significant conditions as follows:

    • Diabetes mellitus or other endocrine disease
    • Eating disorder
    • Acute or chronic inflammatory disease or autoimmune disease
    • Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke, or heart valve problem
    • Having a history of an abnormal electrocardiogram (ECG) unless permitted to proceed in the judgment of the Study Investigator/Sub-Investigator(s)
    • Gastrointestinal disease including gallbladder problems, gallstones, or biliary tract obstruction
    • Thyroid disease (unless on a stable dose of medication for 3 months before Screening/baseline and unlikely to change medication or dose during the study)
    • Hypertension (unless on a stable dose of medication for 3 months before Screening/baseline and unlikely to change medication or dose during the study)
    • Neurologic condition/disease
    • Cancer (unless skin cancer other than melanoma which has been treated > 3 years before Screening/baseline)
    • Liver, pancreatic, and kidney disease
    • Pulmonary disease
    • Blood coagulation disorder or other hematologic disease
    • Other condition or medication use that would preclude participation in the study in the judgment of the Study Investigator/Sub-Investigator
  11. Currently taking any medications or treatment for a psychiatric disorder (bipolar disorder, manic disorder, schizophrenia, apathetic [inherited] disorder), including antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs), tricyclic and atypical antidepressants, benzodiazepines, CNS depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs), pentazocine, phenothiazines, and tramadol. These may preclude participation in the study depending on the judgment of the Study Investigator/Sub-Investigator
  12. Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including DHEA, estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study). This may preclude participation in the study depending on the judgment of the Study Investigator/Sub-Investigator
  13. Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-Investigator, would preclude participation in the study
  14. Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
  15. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the study period
  16. History of known or suspected substance abuse (e.g., alcohol, opiates, Benzodiazepines, or amphetamines)
  17. Having any other circumstance that precludes study participation in the judgment of the Study Investigator/Sub-Investigator including use of other nutritional supplements, which will be evaluated on a case-by-case basis
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05170113


Locations
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United States, Florida
Life Extension Clinical Research
Fort Lauderdale, Florida, United States, 33304
Sponsors and Collaborators
Supplement Formulators, Inc.
Investigators
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Principal Investigator: Andrew Swick, PhD Life Extension
More Information
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Publications:
Alpinia. (2019, October 7). Natural medicines (database on the Internet). Somerville, MA: Therapeutic Research Center. Retrieved from https://naturalmedicines.therapeuticresearch.com/databases/food,-herbssupplements/professional.aspx?productid=276
Caffeine. (2020, January 6). Natural Medicines (database on the Internet). Somerville, MA: Therapeutic Research Center. Retrieved from https://naturalmedicines.therapeuticresearch.com/references.aspx?productid=979
Chudiwal, A., Jain, D., & Somani, R. (2010). Alpinia galanga Willd.-An overview on phytopharmacological properties. Indian Journal of Natural Products and Resources, 1(2), 143-149.
Dallal, G. (2017, July 10). www.Randomization.com. Retrieved from Randomization.com: http://www.randomization.com
Office of New Drugs. (2005). Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. 1-37. Office of the Federal Register , National Archives and Record Administration.
Rosner, B. (n.d.). Hypothesis Testing: Two-Sample Inference-Estimation of Sample Size and Power for Comparing Two Means. In B. Rosner, Fundamentals of Biostatistics. Cengage Learning. Retrieved from www.stat.buc.ca: https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html
Sivanandan, S., & Pimple, S. (2018). Molecular Docking Studies of Alpinia galanga Phytoconstituents for Psychostimulant Activity. Advances in Biological Chemistry, 8(4),69-80
Srivastava, S., & Pimple, S. (2017). Effects of Cymbopogon Flexuosus, Alpinia Galanga and Glycyrrhiza Glabra on attention: A radnomized double-blind, placebo-controlled study. BAOJ Nutrition, 3, 042
Srivastava, S., & Pimple, S. (2017). Effects of Cymbopogon Flexuosus, Alpinia Galanga, and Glycyrrhiza Glabra on attention: A randomized double-blind, placebo-controlled pilot study. BAOJ Nutrition, 3, 042.

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Responsible Party: Supplement Formulators, Inc.
ClinicalTrials.gov Identifier: NCT05170113    
Other Study ID Numbers: CL101
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Supplement Formulators, Inc.:
Energy
Fatigue
Tired
 Sleep
Cognitive Health
Mental Acuity
Additional relevant MeSH terms:
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Fatigue
Mental Fatigue
Behavioral Symptoms
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