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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
Full 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.
Enrollment
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Inclusion criteria
Exclusion criteria
Not having the basic skills needed to operate a smartphone, tablet, or computer
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
Having smoked any cigarette, electronic cigarette, cigar, or pipe, or used marijuana, any recreational drug or cannabidiol (CBD) in the past 30 days
Donated blood within the 30 days prior to Screening/baseline
Having participated in another study within 30 days before Screening/baseline
Being pregnant or planning on becoming pregnant during study participation; or breast feeding
History of allergy or sensitivity to any component of the study products
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
Having been diagnosed, received medical treatment, or taking medication daily for any of the following medical condition(s):
Presence of active or recurring clinically significant conditions as follows:
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
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
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
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)
Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the study period
History of known or suspected substance abuse (e.g., alcohol, opiates, Benzodiazepines, or amphetamines)
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
Primary purpose
Allocation
Interventional model
Masking
79 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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