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

Radicle Science

Status: Completed

Conditions: GI Disorders; Digestion; Abdominal Pain

Treatments: Dietary Supplement: Radicle GI Health Placebo Control Form 3; Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage; Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control Form 1; Dietary Supplement: Radicle GI Health Active Study Product 2.2 Usage; Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage; Dietary Supplement: Radicle GI Health Placebo Control Form 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06009614

RADX-2307

Details and patient eligibility

About

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on gastrointestinal (GI) health and other health outcomes

Full description

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less bloating or indigestion, (2) indicate an interest in taking a health and wellness product to potentially help their bloating or indigestion, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during 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: 2,180 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• Resides in the United States
• Endorses less bloating or indigestion as a primary desire
• Has the opportunity for at least 20% improvement in their primary health outcome score
• 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

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• The calculated validated health survey (PRO) score during enrollment represents less than mild severity
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in another clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
• Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHAA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,180 participants in 7 patient groups, including a placebo group

Placebo Control 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

Active Product 2.2

Experimental group

Description:

GI Health Product Form 2 - active product 2

Treatment:

Dietary Supplement: Radicle GI Health Active Study Product 2.2 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