NCT05170113

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fatigue

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alpinia galanga formulation	Alpinia galanga formulation capsule- 1 capsule daily
DIETARY_SUPPLEMENT	Theacrine formulation	Theacrine formulation capsule- 1 capsule daily
DIETARY_SUPPLEMENT	Caffeine formulation	Caffeine formulation capsule- I capsule daily
DIETARY_SUPPLEMENT	Placebo	Placebo capsule- 1 capsule daily

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2021-12-27
• Last updated: 2022-07-28

Locations

1 site across 1 country: United States