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

Sponsor

Supplement Formulators, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05170113

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Nov 2, 2021

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

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

Primary Outcome Measures

VAS-F (Visual Analogue Scale to Evaluate Fatigue Severity) [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

BCAT-SF (Brief Cognitive Health Assessment Short Form) [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

LSEQ (Leeds Sleep Evaluation Questionnaires) [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.
SF-36 Health Survey (Short Form 36) [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

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ambulatory, male or female, 30-70 years of age
A body mass index (BMI) of 18.5 - 34.9
Admits to experiencing occasional fatigue (tiredness) and would like more energy
Has consumed no more than two cups of coffee or caffeinated beverage per day for seven or more days before Screening/baseline
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
Able to complete tests online with a computer
Able to print out and return documents by scan, email, or mail
Has regular daytime work hours or shifts, if employed (regular shift excludes night shift workers and those with rotating shifts)
Generally healthy and having no significant difficulty with digestion or absorption of food
Able to complete an Activity Log and Study Product Log daily
Has been generally weight stable for the past six months (give or take 6 lbs.)
Willing and able to give written informed consent
Clearly understands the procedures and study requirements
Willing and able to comply with all study procedures, as per protocol
Able to communicate, including reading, in English
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:

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):

Chronic fatigue syndrome
Fibromyalgia
Sleep disorder, including sleep apnea

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

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