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

NCT05170113 | Completed

• 1 other identifier: CL101
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Conditions

Fatigue

Keywords

Energy; Fatigue; Tired; Sleep; Cognitive Health; Mental Acuity

Outcome Measures

Primary Outcomes (1)

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

  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.

  14 Days

Secondary Outcomes (1)

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

  14 Days

Other Outcomes (2)

• LSEQ (Leeds Sleep Evaluation Questionnaires)

  14 Days

• SF-36 Health Survey (Short Form 36)

  14 Days

Study Arms (4)

Alpinia galanga formulation

ACTIVE COMPARATOR

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

Theacrine formulation

ACTIVE COMPARATOR

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

Caffeine formulation.

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Alpinia galanga formulation DIETARY_SUPPLEMENT

Alpinia galanga formulation capsule- 1 capsule daily

Alpinia galanga formulation

Theacrine formulation DIETARY_SUPPLEMENT

Theacrine formulation capsule- 1 capsule daily

Theacrine formulation

Caffeine formulation DIETARY_SUPPLEMENT

Caffeine formulation capsule- I capsule daily

Caffeine formulation.

Placebo DIETARY_SUPPLEMENT

Placebo capsule- 1 capsule daily

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Life Extension Clinical Research

Fort Lauderdale, Florida, 33304, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Swick, PhD

  Life Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 27, 2021
• Study Start: November 2, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)