Aging, Cognitive Decline, Brain Fog, Cognitive Function
Conditions
Keywords
mitochondria, brain, cognition, aging
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTActive Product
Novel Nutritional Product targeting Cognition
DIETARY_SUPPLEMENTPlacebo Product
Identical placebo product
Sponsors
Amazentis SA
Radicle Science (sponsor)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 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
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 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) |
| Sleep-related impairment | 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) |
| Cognitive abilities | 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) |
| Cognitive function (brain health) via smartphone application assessments | 8 weeks | Change in cognitive function evaluated with DANA Brain Vital app |
| Minimal clinically important difference (MCID) in cognitive function | 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) |
| Minimal clinically important difference (MCID) in fatigue | 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) |
| Minimal clinically important difference (MCID) in cognitive abilities | 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) |
| Minimal clinically important difference (MCID) in sleep | 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) |
| Adverse Events | 8 weeks | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Hewlings, PhD
Radicle Science Inc.
Outcome results
None listed