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Trials / Completed

CompletedNCT06201689

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

Radicle Energy™ 24: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
5,543 (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 fatigue 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 more energy/less fatigue, (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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTEnergy Placebo Control Form 1Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 1.1 UsageParticipants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 1.2 UsageParticipants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Placebo Control Form 2Participants will use their Radicle Energy Placebo Control Form 2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 2.1 UsageParticipants will use their Radicle Energy Active Study Product 2.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Placebo Control Form 3Participants will use their Radicle Energy Placebo Control Form 3 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 3.1 UsageParticipants will use their Radicle Energy Active Study Product 3.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Placebo Control Form 4Participants will use their Radicle Energy Placebo Control Form 4 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 4.1 UsageParticipants will use their Radicle Energy Active Study Product 4.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 4.2 UsageParticipants will use their Radicle Energy Active Study Product 4.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 4.3 UsageParticipants will use their Radicle Energy Active Study Product 4.3 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Placebo Control Form 5.1.0Participants will use their Radicle Energy Placebo Control Form 5.0 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 5.1.1 UsageParticipants will use their Radicle Energy Active Study Product 5.1.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Placebo Control Form 5.3.0Participants will use their Radicle Energy Placebo Control Form 5.3 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 5.3.1 UsageParticipants will use their Radicle Energy Active Study Product 5.3.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 5.3.2 UsageParticipants will use their Radicle Energy Active Study Product 5.3.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Placebo Control Form 5.2.0Participants will use their Radicle Energy Placebo Control Form 5.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTEnergy Active Study Product 5.2.1 UsageParticipants will use their Radicle Energy Active Study Product 5.2.1 as directed for a period of 6 weeks.

Timeline

Start date
2024-02-01
Primary completion
2025-07-10
Completion
2025-07-10
First posted
2024-01-11
Last updated
2025-07-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06201689. Inclusion in this directory is not an endorsement.