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

Abdominal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06009614
• Other study ID #: RADX-2307
• Status: Completed
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: May 2024
• Source: Radicle Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2180
• Est. completion date: February 20, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Digestion
• GI Disorders

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Radicle Science, Inc	Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Minimal clinically important difference (MCID) in abdominal pain	Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A	6 weeks
Secondary	Minimal clinically important difference (MCID) in gas/bloating	Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A	6 weeks

External Links

•   Radicle Science, Inc