FatigueNCT05170113
Evaluate the Effectiveness and Safety of the Alpinia Galanga Formulation, Theacrine Formulation, and Caffeine Formulation on Fatigue, Mental Acuity, and Cognitive Health
A study testing Alpinia galanga formulation, Theacrine formulation and Caffeine formulation in people with Fatigue, run by Supplement Formulators, Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Alpinia galanga formulation, Theacrine formulation and Caffeine formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Life Extension Clinical Research
Fort Lauderdale, Florida, 33304
About this study
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
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
Read the 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
- Being tested
- Alpinia galanga formulation, Theacrine formulation, Caffeine formulation, Placebo
- Keywords
- Energy, Fatigue, Tired, Sleep, Cognitive Health, Mental Acuity
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpinia galanga formulationDietary supplement
Alpinia galanga formulation capsule- 1 capsule daily
Theacrine formulationDietary supplement
Theacrine formulation capsule- 1 capsule daily
Caffeine formulationDietary supplement
Caffeine formulation capsule- I capsule daily
PlaceboDietary supplement
Placebo capsule- 1 capsule daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 Days
Secondary outcomes (1)
BCAT-SF (Brief Cognitive Health Assessment Short Form)
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.
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start2 Nov 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Swick, PhD, Principal investigator, Life Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170113
- Sponsor's protocol ID
- CL101
- Status last verified
- Jul 2022
- First submitted
- 9 Dec 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alajmi MF, Mothana RA, Al-Rehaily AJ, Khaled JM. Antimycobacterial Activity and Safety Profile Assessment of Alpinia galanga and Tinospora cordifolia. Evid Based Complement Alternat Med. 2018 Jul 8;2018:2934583. doi: 10.1155/2018/2934583. eCollection 2018.
PubMed 30069222Alpinia. (2019, October 7). Natural medicines (database on the Internet). Somerville, MA: Therapeutic Research Center. Retrieved from https://naturalmedicines.therapeuticresearch.com/databases/food,-herbssupplements/professional.aspx?productid=276
Bello ML, Walker AJ, McFadden BA, Sanders DJ, Arent SM. The effects of TeaCrine(R) and caffeine on endurance and cognitive performance during a simulated match in high-level soccer players. J Int Soc Sports Nutr. 2019 Apr 18;16(1):20. doi: 10.1186/s12970-019-0287-6.
PubMed 30999897Brice CF, Smith AP. Effects of caffeine on mood and performance: a study of realistic consumption. Psychopharmacology (Berl). 2002 Nov;164(2):188-92. doi: 10.1007/s00213-002-1175-2. Epub 2002 Sep 4.
PubMed 12404081Caffeine. (2020, January 6). Natural Medicines (database on the Internet). Somerville, MA: Therapeutic Research Center. Retrieved from https://naturalmedicines.therapeuticresearch.com/references.aspx?productid=979
Carman AJ, Dacks PA, Lane RF, Shineman DW, Fillit HM. Current evidence for the use of coffee and caffeine to prevent age-related cognitive decline and Alzheimer's disease. J Nutr Health Aging. 2014 Apr;18(4):383-92. doi: 10.1007/s12603-014-0021-7.
PubMed 24676319Chudiwal, A., Jain, D., & Somani, R. (2010). Alpinia galanga Willd.-An overview on phytopharmacological properties. Indian Journal of Natural Products and Resources, 1(2), 143-149.
Clewell A, Hirka G, Glavits R, Palmer PA, Endres JR, Murbach TS, Marx T, Pasics Szakonyine I. A 90-Day Oral Toxicological Evaluation of the Methylurate Purine Alkaloid Theacrine. J Toxicol. 2016;2016:6206859. doi: 10.1155/2016/6206859. Epub 2016 Aug 22.
PubMed 27635133Dallal, G. (2017, July 10). www.Randomization.com. Retrieved from Randomization.com: http://www.randomization.com
Fredholm BB, Battig K, Holmen J, Nehlig A, Zvartau EE. Actions of caffeine in the brain with special reference to factors that contribute to its widespread use. Pharmacol Rev. 1999 Mar;51(1):83-133. No abstract available.
PubMed 10049999Ghosh S, Rangan L. Alpinia: the gold mine of future therapeutics. 3 Biotech. 2013 Jun;3(3):173-185. doi: 10.1007/s13205-012-0089-x. Epub 2012 Sep 18.
PubMed 28324376Haller CA, Jacob P 3rd, Benowitz NL. Pharmacology of ephedra alkaloids and caffeine after single-dose dietary supplement use. Clin Pharmacol Ther. 2002 Jun;71(6):421-32. doi: 10.1067/mcp.2002.124523.
PubMed 12087345Haskell CF, Kennedy DO, Wesnes KA, Scholey AB. Cognitive and mood improvements of caffeine in habitual consumers and habitual non-consumers of caffeine. Psychopharmacology (Berl). 2005 Jun;179(4):813-25. doi: 10.1007/s00213-004-2104-3. Epub 2005 Jan 28.
PubMed 15678363Taylor L, Mumford P, Roberts M, Hayward S, Mullins J, Urbina S, Wilborn C. Safety of TeaCrine(R), a non-habituating, naturally-occurring purine alkaloid over eight weeks of continuous use. J Int Soc Sports Nutr. 2016 Jan 13;13:2. doi: 10.1186/s12970-016-0113-3. eCollection 2016.
PubMed 26766930He H, Ma D, Crone LB, Butawan M, Meibohm B, Bloomer RJ, Yates CR. Assessment of the Drug-Drug Interaction Potential Between Theacrine and Caffeine in Humans. J Caffeine Res. 2017 Sep 1;7(3):95-102. doi: 10.1089/jcr.2017.0006.
PubMed 28875060
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05170113
- Acronym / sponsor ID
- CL101
- Conditions
- Fatigue
- Keywords
- Energy, Fatigue, Tired, Sleep, Cognitive Health, Mental Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alpinia galanga formulation | Active comparator | Dietary Supplement: Alpinia galanga formulationAlpinia 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 | Active comparator | Dietary Supplement: Theacrine formulationTheacrine formulation capsule: Take one (1) capsule once daily at noon with 8 oz. (240 ml) of water for a 14-day dosing period |
| Caffeine formulation. | Active comparator | Dietary Supplement: Caffeine formulationCaffeine formulation capsule: Take one (1) capsules once daily at noon with 8 oz.(240 ml) of water for a 14-day dosing period |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule: Take one (1) capsule once daily at noon with 8 oz. (240 ml) of water for a 14-day dosing period |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpinia galanga formulationAlpinia galanga formulation capsule- 1 capsule daily | Dietary supplement | Alpinia galanga formulation |
| Theacrine formulationTheacrine formulation capsule- 1 capsule daily | Dietary supplement | Theacrine formulation |
| Caffeine formulationCaffeine formulation capsule- I capsule daily | Dietary supplement | Caffeine formulation. |
| PlaceboPlacebo capsule- 1 capsule daily | Dietary supplement | Placebo |
Primary outcome
VAS-F (Visual Analogue Scale to Evaluate Fatigue Severity)
Time frame: 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.
1 secondary outcome
BCAT-SF (Brief Cognitive Health Assessment Short Form)
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 30069222Alajmi MF, Mothana RA, Al-Rehaily AJ, Khaled JM. Antimycobacterial Activity and Safety Profile Assessment of Alpinia galanga and Tinospora cordifolia. Evid Based Complement Alternat Med. 2018 Jul 8;2018:2934583. doi: 10.1155/2018/2934583. eCollection 2018.
- BackgroundAlpinia. (2019, October 7). Natural medicines (database on the Internet). Somerville, MA: Therapeutic Research Center. Retrieved from https://naturalmedicines.therapeuticresearch.com/databases/food,-herbssupplements/professional.aspx?productid=276
- Background: PubMed 30999897Bello ML, Walker AJ, McFadden BA, Sanders DJ, Arent SM. The effects of TeaCrine(R) and caffeine on endurance and cognitive performance during a simulated match in high-level soccer players. J Int Soc Sports Nutr. 2019 Apr 18;16(1):20. doi: 10.1186/s12970-019-0287-6.
- Background: PubMed 12404081Brice CF, Smith AP. Effects of caffeine on mood and performance: a study of realistic consumption. Psychopharmacology (Berl). 2002 Nov;164(2):188-92. doi: 10.1007/s00213-002-1175-2. Epub 2002 Sep 4.
- BackgroundCaffeine. (2020, January 6). Natural Medicines (database on the Internet). Somerville, MA: Therapeutic Research Center. Retrieved from https://naturalmedicines.therapeuticresearch.com/references.aspx?productid=979
- Background: PubMed 24676319Carman AJ, Dacks PA, Lane RF, Shineman DW, Fillit HM. Current evidence for the use of coffee and caffeine to prevent age-related cognitive decline and Alzheimer's disease. J Nutr Health Aging. 2014 Apr;18(4):383-92. doi: 10.1007/s12603-014-0021-7.
- BackgroundChudiwal, A., Jain, D., & Somani, R. (2010). Alpinia galanga Willd.-An overview on phytopharmacological properties. Indian Journal of Natural Products and Resources, 1(2), 143-149.
- Background: PubMed 27635133Clewell A, Hirka G, Glavits R, Palmer PA, Endres JR, Murbach TS, Marx T, Pasics Szakonyine I. A 90-Day Oral Toxicological Evaluation of the Methylurate Purine Alkaloid Theacrine. J Toxicol. 2016;2016:6206859. doi: 10.1155/2016/6206859. Epub 2016 Aug 22.
- BackgroundDallal, G. (2017, July 10). www.Randomization.com. Retrieved from Randomization.com: http://www.randomization.com
- Background: PubMed 10049999Fredholm BB, Battig K, Holmen J, Nehlig A, Zvartau EE. Actions of caffeine in the brain with special reference to factors that contribute to its widespread use. Pharmacol Rev. 1999 Mar;51(1):83-133. No abstract available.
- Background: PubMed 28324376Ghosh S, Rangan L. Alpinia: the gold mine of future therapeutics. 3 Biotech. 2013 Jun;3(3):173-185. doi: 10.1007/s13205-012-0089-x. Epub 2012 Sep 18.
- Background: PubMed 12087345Haller CA, Jacob P 3rd, Benowitz NL. Pharmacology of ephedra alkaloids and caffeine after single-dose dietary supplement use. Clin Pharmacol Ther. 2002 Jun;71(6):421-32. doi: 10.1067/mcp.2002.124523.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Swick, PhD principal investigator
Life Extension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpinia galanga formulation, Theacrine formulation and Caffeine formulation in people with Fatigue, run by Supplement Formulators, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS-F (Visual Analogue Scale to Evaluate Fatigue Severity) (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170113, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.