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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

Fatigue Clinical Trial

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

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05170113
Study type Interventional
Source Supplement Formulators, Inc.
Contact
Status Completed
Phase N/A
Start date November 2, 2021
Completion date May 31, 2022
View Details
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