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Active, Not Recruiting

NCT Number: NCT07060898

Impact of a Novel Brain Longevity Supplement Containing the Postbiotic Urolithin A (Mitopure) 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc Office

Encinitas, California, 92024, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

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

Treatment and study plan

Active product

Dietary Supplement

Novel Nutritional Product targeting Cognition

Placebo product

Dietary Supplement

Identical placebo product

Primary outcomes

  1. Cognitive function

    Time frame: 8 weeks

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

Secondary outcomes

  1. Fatigue

    Time frame: 8 weeks

    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)

  2. Sleep-related impairment

    Time frame: 8 weeks

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

  3. Cognitive abilities

    Time frame: 8 weeks

    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)

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

    Time frame: 8 weeks

    Change in cognitive function evaluated with DANA Brain Vital app

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

    Time frame: 8 weeks

    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)

  6. Minimal clinically important difference (MCID) in fatigue

    Time frame: 8 weeks

    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)

  7. Minimal clinically important difference (MCID) in sleep

    Time frame: 8 weeks

    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)

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

    Time frame: 8 weeks

    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)

  9. Adverse Events

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • Radicle Science (sponsor)

Registry information

Official study 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

Acronym: CLARITY

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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