Cognitive FunctionNCT07245784
Radicle Clarity™ RBB: A Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes
A study testing Clarity Active Product 1 in people with Cognitive Function, run by Radicle Science at 1 site in United States.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function 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
- Cognitive Function
- What is being tested?
- Clarity Active Product 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to 19 May 2026
- 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 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 surveys (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
Show all 20Show fewer
- 3.2 Exclusion
- Individuals who report any of the following during screening will 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
- 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
- Lack of reliable daily access to the internet
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle Clarity™ RBB: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function 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) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. 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 13 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world.
- Conditions
- Cognitive Function
- Being tested
- Clarity Product Placebo Control, Clarity Active Product 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarity Product Placebo ControlDietary supplement
Participants will use their Clarity Product Control as directed for a period of 12 weeks
Clarity Active Product 1Dietary supplement
Participants will use their Clarity Active Product (active ingredient: Himalayan Tartary buckwheat, a high-polyphenol non-grain fruit seed) as directed for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Clarity Active Product 1 | Experimental | Clarity Active Product 1 Receives: Dietary Supplement: Clarity Active Product 1 |
| Clarity Placebo Control | Placebo comparator | Clarity Product Placebo Control Receives: Dietary Supplement: Clarity Product Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 13 weeks
Secondary outcomes (3)
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: 13 weeks
Change in sleep-related impairment
Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)
Measured: 13 weeks
Change in cognitive abilities
Change in cognitive abilities: Difference between rates of change over time in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start4 Dec 2025
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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 completing baseline will be stratified based on their sex assignment at birth, health outcome score, and age 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 the study insert with instructions for use and study participation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jeff Bland, Austin Perlmutter
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245784
- Sponsor's protocol ID
- RADX_P_2406_RBB
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Clarity™ RBB: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT07245784
- Acronym / sponsor ID
- RADX_P_2406_RBB
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Collaborators
- Jeff Bland, Austin Perlmutter
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 24 Nov 2025 (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.
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Cognitive Function 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) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. 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 13 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Eligible participants completing baseline will be stratified based on their sex assignment at birth, health outcome score, and age 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 the study insert with instructions for use and study participation.
| Arm | Type | Receives |
|---|---|---|
| Clarity Active Product 1 | Experimental | Dietary Supplement: Clarity Active Product 1Clarity Active Product 1 |
| Clarity Placebo Control | Placebo comparator | Dietary Supplement: Clarity Product Placebo ControlClarity Product Placebo Control |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clarity Product Placebo ControlParticipants will use their Clarity Product Control as directed for a period of 12 weeks | Dietary supplement | Clarity Placebo Control |
| Clarity Active Product 1Participants will use their Clarity Active Product (active ingredient: Himalayan Tartary buckwheat, a high-polyphenol non-grain fruit seed) as directed for a period of 12 weeks. | Dietary supplement | Clarity Active Product 1 |
Primary outcome
Change in cognitive function
Time frame: 13 weeks
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)
3 secondary outcomes
Change in fatigue
Time frame: 13 weeks
Change in sleep-related impairment
Time frame: 13 weeks
Change in cognitive abilities
Time frame: 13 weeks
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 27 May 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. This study is not recruiting at the moment.
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 Clarity Active Product 1 in people with 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?
The sponsor lists 20 inclusion and 0 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 27 May 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?
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?
Change in cognitive function (time frame: 13 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 27 May 2026.