Metabolic Health
Conditions
Brief summary
Radicle HealthTM VIP: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on metabolic health 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 screening 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 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 up to 27 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Interventions
DIETARY_SUPPLEMENTPlacebo Metabolic Control 1
Participants will use their Placebo Metabolic Control 1 as directed for a period of 24 weeks
DIETARY_SUPPLEMENTActive Metabolic Product 1
Participants will use their Active Metabolic Product 1 as directed for a period of 24 weeks
Sponsors
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Intervention model description
Eligible participants will complete all enrollment requirements before being stratified based on sex at birth, age, CGM collection participation, additional biomarker collection participation, and health outcome score. Participants will then be randomized sequentially to a study product group using all stratification factors collectively to support balanced distribution across groups. Following randomization, participants will receive their assigned study product along with instructions outlining product use and study procedures.
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion- 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 PROs (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- Individuals who report any of the following during screening may 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 at a 7th grade level * 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. This may include: * 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. This may include: * 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 and/or pose a safety risk * Lack of reliable daily access to the internet * Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker collection. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the collection. No alternative collection pathway is available under the current protocol. * To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be presented with the biomarker collection consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the collection. These participants will otherwise proceed through full main study enrollment and participation without interruption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Metabolic | 27 weeks | A metabolic test assessed by an at-home (direct-to-consumer) biospecimen (dried blood from a finger-prick) assay. |
Countries
United States
Contacts
CONTACTStudy Manager
CONTACTSusan Hewlings
PRINCIPAL_INVESTIGATORSusan Hewlings
Radicle Science
Outcome results
None listed