Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes

NCT05502328 | Completed

• 1 other identifier: RADX-22D02
• Study Type: interventional
• Target: 1,427
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes

Conditions

Energy

Outcome Measures

Primary Outcomes (2)

• Change in energy

  Change in mean energy score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 7a (scale 1-5; where lower score is less fatigue)

  4 weeks

• Change in focus

  Change in concentration (ability to focus) score as assessed by PROMIS™ Cognition 6a (scale 1-5; where lower score is worse focus (cognitive function))

  4 weeks

Secondary Outcomes (5)

• Change in energy (measure 2)

  4 weeks

• Change in body weight

  4 weeks

• Change in appetite

  4 weeks

• Change in overall quality of life (QOL)

  4 weeks

• Change in overall well-being

  4 weeks

Other Outcomes (4)

• Change in pain

  4 weeks

• Change in Sleep quality

  4 weeks

• Change in feelings of anxiety

  4 weeks

Study Arms (6)

Control 1

PLACEBO COMPARATOR

Energy Product Form 1 - control

Dietary Supplement: Energy Study Product Usage

Control 2

PLACEBO COMPARATOR

Energy Product Form 2 - control

Dietary Supplement: Energy Study Product Usage

Energy Product 1.1

EXPERIMENTAL

Energy Product Form 1 - active product 1

Dietary Supplement: Energy Study Product Usage

Energy Product 1.2

EXPERIMENTAL

Energy Product Form 1 - active product 2

Dietary Supplement: Energy Study Product Usage

Energy Product 2.1

EXPERIMENTAL

Energy Product Form 2 - active 1

Dietary Supplement: Energy Study Product Usage

Energy Product 2.2

EXPERIMENTAL

Energy Product Form 2 - active 2

Dietary Supplement: Energy Study Product Usage

Interventions

Energy Study Product Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Energy study product as directed for a period of 4 weeks.

Control 1; Control 2; Energy Product 1.1; Energy Product 1.2; Energy Product 2.1; Energy Product 2.2

Eligibility Criteria

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

You may qualify if:

• years of age and older
• Resides in the United States
• Endorses: a desire for more energy (less fatigue) and/or a desire for better concentration (focus/attention)
• Selects more energy and/or better concentration as a primary reason for taking a cannabinoid product
• Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e.
• CBD, THC) for the duration of participant engagement
• Expresses a willingness to take a study product and not knowing the product identity until the end of the study

You may not qualify if:

• Pregnant, trying to become pregnant, or breastfeeding Reports a diagnosis of liver disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Calculated BMI 18.5 or less

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

Study Officials

• Emily K Pauli, PharmD

  Radicle Science Inc.

  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 and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 16, 2022
• Study Start: August 17, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 24, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)