Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

Radicle Science

Status: Enrolling

Conditions: GI Disorders; Digestion; Abdominal Pain

Treatments: Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control 7.2; Dietary Supplement: Radicle GI Health Placebo Control Form 3; Dietary Supplement: Radicle GI Health Active Study Product 7.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control Form 4; Dietary Supplement: Radicle GI Health Active Study Product 4.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control 7.3.0; Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage; Dietary Supplement: Radicle GI Health Active Study Product 7.4.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control Form 1; Dietary Supplement: Radicle GI Health Active Study Product 5.1 Usage; Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control Form 7; Dietary Supplement: Radicle GI Health Placebo Control 7.4.0; Dietary Supplement: Radicle GI Health Active Study Product 7.2.1 Usage; Dietary Supplement: Radicle GI Health Active Study Product 7.3.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control Form 5; Dietary Supplement: Radicle GI Health Placebo Control Form 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06376695

RADX-P-2407

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

Full description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) 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 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.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion 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 surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains
• Has the opportunity for at least 20% 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. NYHA (New York Heart Association) Class Ill 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, MAOls (monoamine oxidase inhibitors), 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 product
• Lack of reliable daily access to the internet

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,100 participants in 18 patient groups, including a placebo group

Placebo Control 1.1

Placebo Comparator group

Description:

GI Health Product Form 1 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control Form 1

Active Product 1.1

Experimental group

Description:

GI Health Product Form 1 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage

Placebo Control 2

Placebo Comparator group

Description:

GI Health Product Form 2 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control Form 2

Active Product 2.1

Experimental group

Description:

GI Health Product Form 2 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage

Placebo Control 3

Placebo Comparator group

Description:

GI Health Product Form 3 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control Form 3

Active Product 3.1

Experimental group

Description:

GI Health Product Form 3 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage

Placebo Control 4

Placebo Comparator group

Description:

GI Health Product Form 4 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control Form 4

Active Product 4.1

Experimental group

Description:

GI Health Product Form 4 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 4.1 Usage

Placebo Control 5

Placebo Comparator group

Description:

GI Health Product Form 5 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control Form 5

Active Product 5.1

Experimental group

Description:

GI Health Product Form 5 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 5.1 Usage

Placebo Control 7.1.0

Placebo Comparator group

Description:

GI Health Product Form 7.1- control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control Form 7

Active Product 7.1.1

Experimental group

Description:

GI Health Product Form 7.1 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 7.1 Usage

Placebo Control 7.2.0

Placebo Comparator group

Description:

GI Health Product Form 7.2 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control 7.2

Active Product 7.2.1

Experimental group

Description:

GI Health Product Form 7.2 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 7.2.1 Usage

Placebo Control 7.3.0

Placebo Comparator group

Description:

GI Health Product Form 7.3 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control 7.3.0

Active Product 7.3.1

Experimental group

Description:

GI Health Product Form 7.3 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 7.3.1 Usage

Placebo Control 7.4.0

Placebo Comparator group

Description:

GI Health Product Form 7.4 - control

Treatment:

Dietary Supplement: Radicle GI Health Placebo Control 7.4.0

Active Product 7.4.1

Experimental group

Description:

GI Health Product Form 7.4 - active product 1

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 7.4.1 Usage