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

Amazentis

Status: Completed

Conditions: Aging; Cognitive Function; Cognitive Decline; Brain Fog

Treatments: Dietary Supplement: Active Product; Dietary Supplement: Placebo Product

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07060898

RADX-SP-2506_RAM

Details and patient eligibility

About

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.

Enrollment: 650 patients

Sex: All

Ages: 40 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

650 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Novel nutritional product (containing Mitopure Urolithin A) targeting improvements in cognitive health

Treatment:

Dietary Supplement: Active Product

Placebo

Placebo Comparator group

Description:

Identical Placebo product

Treatment:

Dietary Supplement: Placebo Product