NCT06009614

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

August 18, 2023

Last Update Submit

May 17, 2024

Conditions

DigestionAbdominal PainGI Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in abdominal pain

    6 weeks

  • Change in gas/bloating

    6 weeks

  • Change in feelings of anxiety

    6 weeks

  • Minimal clinically important difference (MCID) in GI-related QOL

    6 weeks

  • Minimal clinically important difference (MCID) in abdominal pain

    6 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Change in mood (emotional distress-depression)

    6 weeks

  • Change in libido

    6 weeks

Study Arms (7)

Placebo Control 1

PLACEBO COMPARATOR

GI Health Product Form 1 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

GI Health Product Form 1 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 1.1 Usage

Placebo Control 2

PLACEBO COMPARATOR

GI Health Product Form 2 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 2

Active Product 2.1

EXPERIMENTAL

GI Health Product Form 2 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 2.1 Usage

Active Product 2.2

EXPERIMENTAL

GI Health Product Form 2 - active product 2

Dietary Supplement: Radicle GI Health Active Study Product 2.2 Usage

Placebo Control 3

PLACEBO COMPARATOR

GI Health Product Form 3 - control

Dietary Supplement: Radicle GI Health Placebo Control Form 3

Active Product 3.1

EXPERIMENTAL

GI Health Product Form 3 - active product 1

Dietary Supplement: Radicle GI Health Active Study Product 3.1 Usage

Interventions

Radicle GI Health Placebo Control Form 1DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1
Radicle GI Health Active Study Product 1.1 UsageDIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1
Radicle GI Health Placebo Control Form 2DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Placebo Control Form 2 as directed for a period of 6 weeks.

Placebo Control 2
Radicle GI Health Active Study Product 2.1 UsageDIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks.

Active Product 2.1
Radicle GI Health Active Study Product 2.2 UsageDIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 2.2 as directed for a period of 6 weeks.

Active Product 2.2
Radicle GI Health Placebo Control Form 3DIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Placebo Control Form 3 as directed for a period of 6 weeks.

Placebo Control 3
Radicle GI Health Active Study Product 3.1 UsageDIETARY_SUPPLEMENT

Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks.

Active Product 3.1

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

MeSH Terms

Conditions

Abdominal PainDigestive System Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Emily K. Pauli, PharmD

    Radicle Science Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be stratified based on gender at birth then randomized to one of the study arms
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start

August 15, 2023

Primary Completion

November 30, 2023

Study Completion

February 20, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Data will not be shared with researchers outside of Radicle Collaborators on this study.

Locations

US(1)