Radicle Recharge: A Study of Health and Wellness Products on Energy Levels and Other Health Outcomes

NCT ID: NCT06104891

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2024-04-30

Brief Summary

A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes

Detailed Description

This is a randomized, double blind. placebo-controlled study conducted with adult participants (study volunteers, citizen scientists), at least 21 years of age at the time of consent and attending the Supply Side West Meeting (SSW) this year.

Eligible participants will (1) endorse a desire for more energy and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known contraindication or with well-established, significant safety concerns due to illness and/or medication(s) will be excluded. Participants that report a known allergy to any possible ingredient they may be exposed to in one of the study arms will be excluded.

Participants will take their assigned study product at a Radicle booth, after enrolling.

Participant reported outcomes (PROs) are collected electronically from eligible participants at baseline (before study product consumption, and for a period of 5 hours after consuming their study product.

Conditions

Energy; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo Control 1

Recharge Product Form 1 - control

Group Type: PLACEBO_COMPARATOR

Recharge Placebo Control 1

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.

Active Product 1

Recharge Product Form 2 - active product 1

Group Type: EXPERIMENTAL

Recharge Active Study Product 1

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.

Active Product 2

Recharge Product Form 3 - active product 1

Group Type: EXPERIMENTAL

Recharge Active Study Product 2

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.

Active Product 3

Recharge Product Form 4 - active product 1

Group Type: EXPERIMENTAL

Recharge Active Study Product 3

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.

Interventions

Recharge Placebo Control 1

Participants will use their Radicle Recharge Placebo Control 1 as directed for a period of 5 hours.

Intervention Type: DIETARY_SUPPLEMENT

Recharge Active Study Product 1

Participants will use their Radicle Recharge Active Study Product 1 as directed for a period of 5 hours.

Intervention Type: DIETARY_SUPPLEMENT

Recharge Active Study Product 2

Participants will use their Radicle Recharge Active Study Product 2 as directed for a period of 5 hours.

Intervention Type: DIETARY_SUPPLEMENT

Recharge Active Study Product 3

Participants will use their Radicle Recharge Active Study Product 3 as directed for a period of 5 hours.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Adults at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities
• Attending the Supply Side West meeting in person
• Able to read and understand English
• Endorses more energy as a primary desire
• 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
• Reports current enrollment in another clinical trial
• Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients.
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
• Reports an allergy to any of the study products ingredients

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radicle Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily K. Pauli, PharmD

Role: PRINCIPAL_INVESTIGATOR

Radicle Science

Locations

Radicle Science, Inc

Del Mar, California, United States

Countries

United States

Related Links

http://radiclescience.com

Radicle Science, Inc

Other Identifiers

RADX-2317

Identifier Type: -

Identifier Source: org_study_id