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

Primary Purpose

Digestion, Abdominal Pain, GI Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GI Health Placebo Control Form 1
GI Health Active Study Product 1.1 Usage
GI Health Placebo Control Form 2
GI Health Active Study Product 2.1 Usage
GI Health Active Study Product 2.2 Usage
GI Health Placebo Control Form 3
GI Health Active Study Product 3.1 Usage
Sponsored by
Radicle Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Digestion

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Radicle Science, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo Control 1

Active Product 1.1

Placebo Control 2

Active Product 2.1

Active Product 2.2

Placebo Control 3

Active Product 3.1

Arm Description

GI Health Product Form 1 - control

GI Health Product Form 1 - active product 1

GI Health Product Form 2 - control

GI Health Product Form 2 - active product 1

GI Health Product Form 2 - active product 2

GI Health Product Form 3 - control

GI Health Product Form 3 - active product 1

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
Minimal clinically important difference (MCID) in abdominal pain
Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
Minimal clinically important difference (MCID) in gas/bloating
Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A

Full Information

First Posted
August 18, 2023
Last Updated
September 19, 2023
Sponsor
Radicle Science
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1. Study Identification

Unique Protocol Identification Number
NCT06009614
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radicle Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestion, Abdominal Pain, GI Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking
Participant
Masking Description
Participants will be blinded to the product they receive.
Allocation
Randomized
Enrollment
2800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control 1
Arm Type
Placebo Comparator
Arm Description
GI Health Product Form 1 - control
Arm Title
Active Product 1.1
Arm Type
Experimental
Arm Description
GI Health Product Form 1 - active product 1
Arm Title
Placebo Control 2
Arm Type
Placebo Comparator
Arm Description
GI Health Product Form 2 - control
Arm Title
Active Product 2.1
Arm Type
Experimental
Arm Description
GI Health Product Form 2 - active product 1
Arm Title
Active Product 2.2
Arm Type
Experimental
Arm Description
GI Health Product Form 2 - active product 2
Arm Title
Placebo Control 3
Arm Type
Placebo Comparator
Arm Description
GI Health Product Form 3 - control
Arm Title
Active Product 3.1
Arm Type
Experimental
Arm Description
GI Health Product Form 3 - active product 1
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Placebo Control Form 1
Intervention Description
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Active Study Product 1.1 Usage
Intervention Description
Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Placebo Control Form 2
Intervention Description
Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Active Study Product 2.1 Usage
Intervention Description
Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Active Study Product 2.2 Usage
Intervention Description
Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Placebo Control Form 3
Intervention Description
Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
GI Health Active Study Product 3.1 Usage
Intervention Description
Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in GI (Gastrointestinal) - related Quality of Life (QOL)
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in abdominal pain
Description
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)
Time Frame
6 weeks
Title
Change in gas/bloating
Description
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)
Time Frame
6 weeks
Title
Change in feelings of anxiety
Description
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in GI-related QOL
Description
Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in abdominal pain
Description
Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in gas/bloating
Description
Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change in mood (emotional distress-depression)
Description
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)
Time Frame
6 weeks
Title
Change in libido
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager
Phone
760-281-3898
Email
studymgmt@radiclescience.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily K. Pauli, PharmD
Organizational Affiliation
Radicle Science, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radicle Science, Inc
City
Del Mar
State/Province
California
ZIP/Postal Code
92014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Management
Phone
760-281-3898
Email
studymgmt@radiclescience.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared with researchers outside of Radicle Collaborators on this study.
Links:
URL
http://radiclescience.com
Description
Radicle Science, Inc

Learn more about this trial

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

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