Stress
Conditions
Brief summary
A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on stress 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 primary 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 cardiac dysfunction, liver or kidney disease may be excluded. 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 baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Interventions
DIETARY_SUPPLEMENTRelaxation Placebo Control
Participants will use their Relaxation Placebo Control as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTRelaxation Active Product 1
Participants will use their Relaxation Active Product 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTRelaxation Active Product 2
Participants will use their Relaxation Active Product 2 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
Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
Yes
Inclusion criteria
Adults, at least 21 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
* 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 and/or pose a known safety risk * Lack of reliable daily access to the internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal clinical importance difference (MCID) in perceived stress | 7 weeks | Likelihood of achieving a MCID in perceived stress, as measured by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress) |
| Change in perceived stress | 7 weeks | Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal clinical importance difference (MCID) in feelings of anxiety | 7 weeks | Likelihood of achieving a MCID in feelings of anxiety, as measured by PROMIS Anxiety 4A (scale 4-20; where the higher scores correspond to worse feelings of anxiety) |
| Change in feelings of anxiety | 7 weeks | Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where the higher scores correspond to worse feelings of anxiety) |
| Change in cognitive function | 7 weeks | Difference between rates of change over time in mood score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where the higher scores correspond to better cognitive function) |
| Minimal clinical importance difference (MCID) in mood | 7 weeks | Likelihood of achieving a MCID in mood, as measured by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to worse mood) |
| Change in mood | 7 weeks | Difference between rates of change over time in mood score as assessed by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to worse mood) |
| Minimal clinical importance difference (MCID) in cognitive function | 7 weeks | Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function 4A (scale 4-20; where the higher scores correspond to better cognitive function) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep disturbance | 7 weeks | Difference between rates of change over time in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where the higher scores correspond to worse sleep disturbance) |
| Minimal clinical importance difference (MCID) in sleep disturbance | 7 weeks | Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance 4A (scale 4-20; where the higher scores correspond to worse sleep disturbance) |
Countries
United States
Outcome results
None listed