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

NCT06104891 | Completed

• 1 other identifier: RADX-2317
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Energy; Fatigue

Outcome Measures

Primary Outcomes (1)

• Change in energy

  Mean difference in energy score as assessed by Energy Visual Analog Scale (VAS) (scale 0 - 10; where 0 is no energy and 10 is more than enough energy)

  5 hours

Secondary Outcomes (5)

• Change in cognitive function

  5 hours

• Change in fatigue

  5 hours

• Minimal clinically important difference (MCID) in energy

  5 hours

• Minimal clinically important difference (MCID) in cognitive function

  5 hours

• Minimal clinically important difference (MCID) in fatigue

  5 hours

Study Arms (4)

Placebo Control 1

PLACEBO COMPARATOR

Recharge Product Form 1 - control

Dietary Supplement: Recharge Placebo Control 1

Active Product 1

EXPERIMENTAL

Recharge Product Form 2 - active product 1

Dietary Supplement: Recharge Active Study Product 1

Active Product 2

EXPERIMENTAL

Recharge Product Form 3 - active product 1

Dietary Supplement: Recharge Active Study Product 2

Active Product 3

EXPERIMENTAL

Recharge Product Form 4 - active product 1

Dietary Supplement: Recharge Active Study Product 3

Interventions

Recharge Placebo Control 1 DIETARY_SUPPLEMENT

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

Placebo Control 1

Recharge Active Study Product 1 DIETARY_SUPPLEMENT

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

Active Product 1

Recharge Active Study Product 2 DIETARY_SUPPLEMENT

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

Active Product 2

Recharge Active Study Product 3 DIETARY_SUPPLEMENT

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

Active Product 3

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily K. Pauli, PharmD

  Radicle Science

  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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on gender at birth, then randomized to one of the study arms

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: October 25, 2023
• Primary Completion: October 26, 2023
• Study Completion: April 30, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)