NCT06074627

Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes

Radicle™ Energy2: A Parallel Group, Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Other Health Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,189 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes

Detailed description

This is a parallel group, randomized, double-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 more energy, (2) have the opportunity for meaningful improvement in their health outcome score, 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 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

• Fatigue
• Energy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Energy Placebo Control Form 1	Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Energy Active Study Product 1.1 Usage	Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Energy Active Study Product 1.2 Usage	Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Energy Active Study Product 1.3 Usage	Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks.

Timeline

• Start date: 2023-09-26
• Primary completion: 2023-12-22
• Completion: 2024-05-03
• First posted: 2023-10-10
• Last updated: 2024-07-10

Locations

1 site across 1 country: United States