Purpose

Radicle GI Health RAA: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on gastrointestinal-related quality of life and related health outcomes.

Condition

Eligibility

Eligible Ages
Between 21 Years and 105 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 and/or use of investigational
drugs

- 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 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

- Reports illicit drug use

- Reports a cancer diagnosis within the last 2 years

- Reports current use of weight loss or appetite modifying medications or supplements
(including GLP-1 receptor agonists)

- Reports current use of prescription stimulant, sedative, sleep, or other central
nervous system-active medications

- Reports current use of prebiotics/probiotics, multivitamin supplements, gut health
supplements, synbiotics, greens powders

- 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
sub-study. 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 sub-study. 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 sub-study consent or any associated
study materials. This automated screening ensures that ineligible participants are
not inadvertently enrolled in the sub-study. These participants will otherwise
proceed through full main study enrollment and participation without interruption.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible participants must complete all enrollment steps to be stratified. Participants will be stratified based on their 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.
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active GI Health Product 1
Active GI Health Product 1
  • Dietary Supplement: Active GI Health Product 1
    Participants will use their Active GI Health Product 1 as directed for a period of 8 weeks"
Placebo Comparator
Placebo GI Health Control
Placebo GI Health Control
  • Dietary Supplement: Placebo GI Health Control
    Participants will use their Placebo GI Health Control as directed for a period of 8 weeks

Recruiting Locations

Radicle Science Inc.
Del Mar, California 92014
Contact:
Study Manager
760-281-3898
studymgmt@radiclescience.com

More Details

Status
Recruiting
Sponsor
Radicle Science

Study Contact

Study Manager
858-779-0086
studymgmt@radiclescience.com

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, (2) currently experience persistent gas, bloating, indigestion, and/or irregular bowel movements for 3 months or more, 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 9 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.