FatigueNCT07745010
Radicle Energy™ DNB: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
A study testing Active Fatigue Product 1A and Active Fatigue Product 1B in people with Fatigue, run by Radicle Science at 1 site in United States.
Trial summary
Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled 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 40 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Active Fatigue Product 1A and Active Fatigue Product 1B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,320 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 13 Aug 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 40 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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 the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
- 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.
United States1 site
Radicle Science Inc.
Del Mar, California, 92014-2605
Study Manager, 760-281-3898, studymgmt@radiclescience.com
Megan Moseley, megan@radiclescience.com
About this study
Official title: Radicle Energy™ DNB: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled 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) be aged 40 and older, (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 9 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
- Being tested
- Active Fatigue Product 1A, Active Fatigue Product 1B, Placebo Fatigue Control 1A, Placebo Fatigue Control 1B
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Fatigue Product 1ADietary supplement
Participants will use their Active Fatigue Product 1A as directed for a period of 8 weeks
Active Fatigue Product 1BDietary supplement
Participants will use their Active Fatigue Product 1B as directed for a period of 8 weeks
Placebo Fatigue Control 1ADietary supplement
Participants will use their Placebo Fatigue Control 1A as directed for a period of 8 weeks
Placebo Fatigue Control 1BDietary supplement
Participants will use their Placebo Fatigue Control 1B as directed for a period of 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Product 1A | Experimental | Active Fatigue Product 1A Receives: Dietary Supplement: Active Fatigue Product 1A |
| Active Product 1B | Experimental | Active Fatigue Product 1B Receives: Dietary Supplement: Active Fatigue Product 1B |
| Placebo Control 1A | Placebo comparator | Placebo Fatigue Control 1A Receives: Dietary Supplement: Placebo Fatigue Control 1A |
| Placebo Control 1B | Placebo comparator | Placebo Fatigue Control 1B Receives: Dietary Supplement: Placebo Fatigue Control 1B |
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: 9 weeks
Secondary outcomes (3)
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: 9 weeks
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: 9 weeks
Change in mental wellbeing
Change in mental wellbeing: Difference between rates of change over time in mental wellbeing score as assessed by World Health Organization-Five Well-Being Index (scale 0-25; where the higher scores correspond to better mental wellbeing)
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start13 Aug 2026 (estimated)
- Primary completion13 Aug 2027 (estimated)
- Study completion13 Aug 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.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- 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 procedures before stratification and randomization. During enrollment, participants will be stratified by sex assigned at birth (female or non-female), age (40-59 or 60+ years), and health outcome score, with score categories defined according to published PROMIS scoring guidelines. These stratification factors create 16 total strata to support balanced allocation across study groups. Participants will then be sequentially randomized within strata to ensure an equal distribution across each study product group. Following randomization, participants will receive their assigned study product along with an informational insert containing product usage instructions and study procedures.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,320 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
- NCT07745010
- Sponsor's protocol ID
- RADX_P_2604_DNB
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Energy™ DNB: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT07745010
- Acronym / sponsor ID
- RADX_P_2604_DNB
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2026 (estimated)
- Primary completion
- 13 Aug 2027 (estimated)
- Study completion
- 13 Aug 2027 (estimated)
- First posted
- 4 Aug 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™ DNB: A randomized, double-blind, placebo-controlled 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) be aged 40 and older, (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 9 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
- 4
- Model description
- Eligible participants must complete all enrollment procedures before stratification and randomization. During enrollment, participants will be stratified by sex assigned at birth (female or non-female), age (40-59 or 60+ years), and health outcome score, with score categories defined according to published PROMIS scoring guidelines. These stratification factors create 16 total strata to support balanced allocation across study groups. Participants will then be sequentially randomized within strata to ensure an equal distribution across each study product group. Following randomization, participants will receive their assigned study product along with an informational insert containing product usage instructions and study procedures.
| Arm | Type | Receives |
|---|---|---|
| Active Product 1A | Experimental | Dietary Supplement: Active Fatigue Product 1AActive Fatigue Product 1A |
| Active Product 1B | Experimental | Dietary Supplement: Active Fatigue Product 1BActive Fatigue Product 1B |
| Placebo Control 1A | Placebo comparator | Dietary Supplement: Placebo Fatigue Control 1APlacebo Fatigue Control 1A |
| Placebo Control 1B | Placebo comparator | Dietary Supplement: Placebo Fatigue Control 1BPlacebo Fatigue Control 1B |
Who may qualify
- Ages
- 40 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Active Fatigue Product 1AParticipants will use their Active Fatigue Product 1A as directed for a period of 8 weeks | Dietary supplement | Active Product 1A |
| Active Fatigue Product 1BParticipants will use their Active Fatigue Product 1B as directed for a period of 8 weeks | Dietary supplement | Active Product 1B |
| Placebo Fatigue Control 1AParticipants will use their Placebo Fatigue Control 1A as directed for a period of 8 weeks | Dietary supplement | Placebo Control 1A |
| Placebo Fatigue Control 1BParticipants will use their Placebo Fatigue Control 1B as directed for a period of 8 weeks | Dietary supplement | Placebo Control 1B |
Primary outcome
Change in fatigue
Time frame: 9 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 sleep
Time frame: 9 weeks
Change in cognitive function
Time frame: 9 weeks
Change in mental wellbeing
Time frame: 9 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 4 Aug 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
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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.
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 Active Fatigue Product 1A and Active Fatigue Product 1B in people with Fatigue, 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?
The sponsor lists 0 inclusion and 13 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: opening soon, as of the sponsor's last update on 4 Aug 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: 9 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 4 Aug 2026.