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

NCT06074627 | Completed

• 1 other identifier: RADX-2304
• Study Type: interventional
• Target: 1,189
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue; Energy

Outcome Measures

Primary Outcomes (1)

• Change in fatigue

  Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

  6 weeks

Secondary Outcomes (7)

• Change in focus (cognitive function)

  6 weeks

• Change in sleep

  6 weeks

• Change in feelings of anxiety

  6 weeks

• Minimal clinically important difference (MCID) in fatigue

  6 weeks

• Minimal clinically important difference (MCID) in focus (cognitive function)

  6 weeks

Other Outcomes (2)

• Change in mood (emotional distress-depression)

  6 weeks

• Change in libido

  6 weeks

Study Arms (4)

Placebo Control 1

PLACEBO COMPARATOR

Energy Product Form 1 - control

Dietary Supplement: Energy Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

Energy Product Form 1 - active product 1

Dietary Supplement: Energy Active Study Product 1.1 Usage

Active Product 1.2

EXPERIMENTAL

Energy Product Form 1 - active product 2

Dietary Supplement: Energy Active Study Product 1.2 Usage

Active Product 1.3

EXPERIMENTAL

Energy Product Form 1 - active product 3

Dietary Supplement: Energy Active Study Product 1.3 Usage

Interventions

Energy Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1

Energy Active Study Product 1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Energy Active Study Product 1.2 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.

Active Product 1.2

Energy Active Study Product 1.3 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks.

Active Product 1.3

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, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses more energy as a primary desire
• Has the opportunity for at least 20% improvement in their primary health outcome score
• 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
• Unable to provide a valid US shipping address and mobile phone number
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in another clinical trial
• Lack of reliable daily access to the internet
• Reports current use of chemotherapy or immunotherapy
• Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
• Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

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 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' study product assignment. Participants are blinded to the study product they are assigned.
• 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 3, 2023
• First Posted: October 10, 2023
• Study Start: September 26, 2023
• Primary Completion: December 22, 2023
• Study Completion: May 3, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)