NCT06376695

Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

Radicle GI Health™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,607 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

Detailed description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at 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.

Conditions

• Abdominal Pain
• GI Disorders
• Digestion

Interventions

Type	Name	Description
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.
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.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control Form 2	Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
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.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control Form 3	Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
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.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control Form 4	Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Active Study Product 4.1 Usage	Participants will use their Radicle GI Health Active Study Product 4.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control Form 5	Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Active Study Product 5.1 Usage	Participants will use their Radicle GI Health Active Study Product 5.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control Form 7	Participants will use their Placebo Control Form 7 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Active Study Product 7.1 Usage	Participants will use their Radicle GI Health Active Study Product 7.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control 7.2	Participants will use their Placebo Control 7.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Active Study Product 7.2.1 Usage	Participants will use their Radicle GI Health Active Study Product 7.2.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control 7.3.0	Participants will use their Placebo Control 7.3 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Active Study Product 7.3.1 Usage	Participants will use their Radicle GI Health Active Study Product 7.3.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Placebo Control 7.4.0	Participants will use their Placebo Control 7.4 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Radicle GI Health Active Study Product 7.4.1 Usage	Participants will use their Radicle GI Health Active Study Product 7.4.1 as directed for a period of 6 weeks.

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-06-05
• Completion: 2025-06-05
• First posted: 2024-04-19
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States