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AgingCLARITYNCT07060898

Impact of a Novel Brain Longevity Supplement Containing the Postbiotic Urolithin A (Mitopure) on Cognitive Function and Related Health Outcomes

A study testing Active Product in people with Aging and Cognitive Decline, run by Amazentis SA at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Cognitive Decline, Brain Fog
What is being tested?
Active Product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
1 siteUnited States
Study dates
29 Jul 2025to 20 Nov 2026
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants must meet all the following criteria:
  • Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
  • o 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

Who cannot join

  • 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
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.
  • o 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.
  • o 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Radicle Science, Inc Office

    Encinitas, California, 92024

Other trials in United States

About this study

Official title: Radicle Clarity™ 25_RAM: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Cognitive Function and Related Health Outcomes

This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Participants will take their assigned study product (active or placebo) for 8 weeks and answer validated electronic surveys assessing cognitive function delivered to them through a text message (SMS) link or through email.

Being tested
Active Product, Placebo Product
Keywords
mitochondria, brain, cognition, aging
Medical subject headings
Cognitive Dysfunction, Mental Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active ProductDietary supplement

    Novel Nutritional Product targeting Cognition

  • Placebo ProductDietary supplement

    Identical placebo product

Study groups in NCT07060898
Study groupRoleWhat they receive
ActiveActive comparatorNovel nutritional product (containing Mitopure Urolithin A) targeting improvements in cognitive health
Receives: Dietary Supplement: Active Product
PlaceboPlacebo comparatorIdentical Placebo product
Receives: Dietary Supplement: Placebo Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive function

    Change in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)

    Measured: 8 weeks

Secondary outcomes (9)

  1. Fatigue

    Change in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to worse fatigue)

    Measured: 8 weeks

  2. Sleep-related impairment

    Change in sleep score as assessed by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)

    Measured: 8 weeks

  3. Cognitive abilities

    Change 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: 8 weeks

  4. Cognitive function (brain health) via smartphone application assessments

    Change in cognitive function evaluated with DANA Brain Vital app

    Measured: 8 weeks

  5. Minimal clinically important difference (MCID) in cognitive function

    Likelihood of achieving minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)

    Measured: 8 weeks

  6. Minimal clinically important difference (MCID) in fatigue

    Likelihood of achieving minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to worse fatigue)

    Measured: 8 weeks

  7. Minimal clinically important difference (MCID) in sleep

    Likelihood of achieving minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)

    Measured: 8 weeks

  8. Minimal clinically important difference (MCID) in cognitive abilities

    Likelihood of achieving minimal clinically important difference 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: 8 weeks

  9. Adverse Events

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start29 Jul 2025
  3. Primary completion20 Nov 2025
  4. Study completion20 Nov 2026 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060898
Sponsor's protocol ID
RADX-SP-2506_RAM
Acronym
CLARITY
Status last verified
Mar 2026
First submitted
2 Jul 2025
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Product in people with Aging and Cognitive Decline, run by Amazentis SA 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 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?

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?

Cognitive function (time frame: 8 weeks). 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 NCT07060898.

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 6 Mar 2026.

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