FatigueNCT07653724
Radicle Energy VBMTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
A study testing Energy Active Product 1 in people with Fatigue and Cognitive Function, run by Radicle Science at 1 site in United States.
Trial summary
Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes. Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Cognitive Function, Global Mental Health
- What is being tested?
- Energy Active Product 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2026to 25 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Participants must meet all the following criteria:
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
3.2 Exclusion
Individuals who report any of the following during screening may be excluded from participation:
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English at a 7th grade level
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
- Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
- Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
- Reports current use of caffeine-alternative products
- Reports consuming 3 or more caffeinated beverages a day
- Lack of reliable daily access to the internet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susan Hewlings contact
United States1 site
Radicle Science Inc.
Del Mar, California, 92014
Study Manager, 760-281-3898, studymgmt@radiclescience.com
Megan Mosely, megan@radiclescience.com
About this study
Official title: Radicle Energy VBMTM: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) consume less than 3 caffeinated beverages a day, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well- established, significant safety concerns due to illness will be
excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Conditions
- Fatigue, Cognitive Function, Global Mental Health, Sleep Disturbance
- Being tested
- Energy Product Placebo Control, Energy Active Product 1
- Medical subject headings
- Fatigue, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Product Placebo ControlDietary supplement
Participants will use their Energy Product Placebo Control as directed for a period of 6 weeks.
Energy Active Product 1Dietary supplement
Participants will use their Energy Active Product 1 as directed for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Energy Product 1 | Experimental | Energy Active Product 1 Receives: Dietary Supplement: Energy Active Product 1 |
| Placebo Energy Control | Placebo comparator | Energy Product Placebo Control Receives: Dietary Supplement: Energy Product Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Measured: 7 weeks
Secondary outcomes (3)
Change in cognitive function
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
Measured: 7 weeks
Change in Global Mental Health
Change in Global Mental Health: Difference in rates of change over time in cognitive function score as assessed by PROMIS Global Mental Health 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Measured: 7 weeks
Change in sleep
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants must complete all enrollment steps to be stratified. Participants will be stratified based on their age, sex assignment at birth, and health outcome score during enrollment, then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and an insert with additional information on product usage and study procedures.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653724
- Sponsor's protocol ID
- RADX_P_2604_VBM
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Energy VBMTM: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT07653724
- Acronym / sponsor ID
- RADX_P_2604_VBM
- Conditions
- Fatigue, Cognitive Function, Global Mental Health, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 17 Jun 2026 (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.
Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) consume less than 3 caffeinated beverages a day, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known contraindication or with well- established, significant safety concerns due to illness will be
excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Eligible participants must complete all enrollment steps to be stratified. Participants will be stratified based on their age, sex assignment at birth, and health outcome score during enrollment, then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and an insert with additional information on product usage and study procedures.
| Arm | Type | Receives |
|---|---|---|
| Active Energy Product 1 | Experimental | Dietary Supplement: Energy Active Product 1Energy Active Product 1 |
| Placebo Energy Control | Placebo comparator | Dietary Supplement: Energy Product Placebo ControlEnergy Product Placebo Control |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Energy Product Placebo ControlParticipants will use their Energy Product Placebo Control as directed for a period of 6 weeks. | Dietary supplement | Placebo Energy Control |
| Energy Active Product 1Participants will use their Energy Active Product 1 as directed for a period of 6 weeks. | Dietary supplement | Active Energy Product 1 |
Primary outcome
Change in fatigue
Time frame: 7 weeks
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
3 secondary outcomes
Change in cognitive function
Time frame: 7 weeks
Change in Global Mental Health
Time frame: 7 weeks
Change in sleep
Time frame: 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
Related trials for Fatigue
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Active, not recruiting
Fatigue in Lupus Intervention Programmes (FLIP)
Systemic Lupus Erythematosus
Not yet recruitingPhase 3
Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease.
Mitochondrial Disease
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
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.
Susan Hewlings contact
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Active Product 1 in people with Fatigue and Cognitive Function, run by Radicle Science 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?
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: opening soon, as of the sponsor's last update on 17 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Manager (858-779-0086, studymgmt@radiclescience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.