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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Pain; Digestion; GI Disorders
• Intervention / Treatment: Dietary supplement: Radicle GI Health Placebo Control Form 1; Dietary supplement: Radicle GI Health Active Study Product 1.1 Usage; Dietary supplement: Radicle GI Health Placebo Control Form 2; Dietary supplement: Radicle GI Health Active Study Product 2.1 Usage; Dietary supplement: Radicle GI Health Active Study Product 2.2 Usage; Dietary supplement: Radicle GI Health Placebo Control Form 3; Dietary supplement: Radicle GI Health Active Study Product 3.1 Usage

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.

• Study Type: Interventional
• Enrollment (Actual): 2180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Manager; Phone Number: 760-281-3898; Email: studymgmt@radiclescience.com

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; GI Health Product Form 1 - control	Dietary supplement: Radicle GI Health Placebo Control Form 1; Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Experimental: Active Product 1.1; GI Health Product Form 1 - active product 1	Dietary supplement: Radicle GI Health Active Study Product 1.1 Usage; Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 2; GI Health Product Form 2 - control	Dietary supplement: Radicle GI Health Placebo Control Form 2; Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Experimental: Active Product 2.1; GI Health Product Form 2 - active product 1	Dietary supplement: Radicle GI Health Active Study Product 2.1 Usage; Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Experimental: Active Product 2.2; GI Health Product Form 2 - active product 2	Dietary supplement: Radicle GI Health Active Study Product 2.2 Usage; Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 3; GI Health Product Form 3 - control	Dietary supplement: Radicle GI Health Placebo Control Form 3; Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Experimental: Active Product 3.1; GI Health Product Form 3 - active product 1	Dietary supplement: Radicle GI Health Active Study Product 3.1 Usage; Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in GI (Gastrointestinal) - related Quality of Life (QOL)	Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in feelings of anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Change in abdominal pain	Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)	6 weeks
Change in gas/bloating	Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)	6 weeks
Minimal clinically important difference (MCID) in GI-related QOL	Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)	6 weeks
Minimal clinically important difference (MCID) in abdominal pain	Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A	6 weeks
Minimal clinically important difference (MCID) in gas/bloating	Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mood (emotional distress-depression)	Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)	6 weeks
Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)	6 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): April 12, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: RADX-2307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No