Clinical trial NCT06009614: Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes
Official title: Radicle™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestion
Abdominal Pain
GI Disorders
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 2180
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be stratified based on gender at birth then randomized to one of the study arms
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in GI (Gastrointestinal) - related Quality of Life (QOL)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in abdominal pain
timeFrame: 6 weeks
measure: Change in gas/bloating
timeFrame: 6 weeks
measure: Change in feelings of anxiety
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in GI-related QOL
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in abdominal pain
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in gas/bloating
timeFrame: 6 weeks
Other outcomes:
measure: Change in mood (emotional distress-depression)
timeFrame: 6 weeks
measure: Change in libido
timeFrame: 6 weeks
Locations:
city: Del Mar
country: United States
facility: Radicle Science, Inc
state: California
Study officials:
affiliation: Radicle Science, Inc
name: Emily K. Pauli, PharmD
role: PRINCIPAL_INVESTIGATOR
References: