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

Not Applicable

Completed

• Conditions: Fatigue
• Interventions: Dietary Supplement: Alpinia galanga formulation; Dietary Supplement: Theacrine formulation; Dietary Supplement: Placebo; Dietary Supplement: Caffeine formulation

• Registration Number: NCT05170113
• Lead Sponsor: Supplement Formulators, Inc.

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

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 Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-27
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Alpinia galanga formulation	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
Theacrine formulation	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
Placebo	Placebo	Placebo capsule: Take one (1) capsule once daily at noon with 8 oz. (240 ml) of water for a 14-day dosing period
Caffeine formulation.	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Life Extension Clinical Research; 🇺🇸 Fort Lauderdale, Florida, United States