Cognitive Function, Fatigue, Global Mental Health, Sleep Disturbance
Conditions
Brief summary
Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue 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) consume less than 3 caffeinated beverages a day, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) 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 7 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_SUPPLEMENTEnergy Product Placebo Control
Participants will use their Energy Product Placebo Control as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Product 1
Participants will use their Energy Active Product 1 as directed for a period of 6 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 must complete all enrollment steps to be stratified. Participants will be stratified based on their age, sex assignment at birth, and health outcome score during enrollment, then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and an insert with additional information on product usage and study procedures.
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
Yes
Inclusion criteria
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 3.2 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. * 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. * 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 caffeine-alternative products * Reports consuming 3 or more caffeinated beverages a day * Lack of reliable daily access to the internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | 7 weeks | Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | 7 weeks | Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function) |
| Change in Global Mental Health | 7 weeks | Change in Global Mental Health: Difference in rates of change over time in cognitive function score as assessed by PROMIS Global Mental Health 4A (scale 4-20; where lower scores correspond to worse cognitive function) |
| Change in sleep | 7 weeks | Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance) |
Countries
United States
Contacts
CONTACTStudy Manager
CONTACTSusan Hewlings
PRINCIPAL_INVESTIGATORSusan Hewlings
Radicle Science
Outcome results
None listed