Radicle Energy™ DNB: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes

NCT07745010 | Not Yet Recruiting

• 1 other identifier: RADX_P_2604_DNB
• Study Type: interventional
• Target: 1,320
• Locations: 1 country
• Sites: 1

Brief Summary

Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• Change in fatigue

  Change in fatigue: Difference in rates of change over time 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)

  9 weeks

Secondary Outcomes (3)

• Change in sleep

  9 weeks

• Change in cognitive function

  9 weeks

• Change in mental wellbeing

  9 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in fatigue

  9 weeks

• Minimal clinically important difference (MCID) in sleep

  9 weeks

• Minimal clinically important difference (MCID) in cognitive function

  9 weeks

Study Arms (4)

Active Product 1A

EXPERIMENTAL

Active Fatigue Product 1A

Dietary Supplement: Active Fatigue Product 1A

Active Product 1B

EXPERIMENTAL

Active Fatigue Product 1B

Dietary Supplement: Active Fatigue Product 1B

Placebo Control 1A

PLACEBO COMPARATOR

Placebo Fatigue Control 1A

Dietary Supplement: Placebo Fatigue Control 1A

Placebo Control 1B

PLACEBO COMPARATOR

Placebo Fatigue Control 1B

Dietary Supplement: Placebo Fatigue Control 1B

Interventions

Active Fatigue Product 1A DIETARY_SUPPLEMENT

Participants will use their Active Fatigue Product 1A as directed for a period of 8 weeks

Active Product 1A

Active Fatigue Product 1B DIETARY_SUPPLEMENT

Participants will use their Active Fatigue Product 1B as directed for a period of 8 weeks

Active Product 1B

Placebo Fatigue Control 1A DIETARY_SUPPLEMENT

Participants will use their Placebo Fatigue Control 1A as directed for a period of 8 weeks

Placebo Control 1A

Placebo Fatigue Control 1B DIETARY_SUPPLEMENT

Participants will use their Placebo Fatigue Control 1B as directed for a period of 8 weeks

Placebo Control 1B

Eligibility Criteria

• Age: 40 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

\- Inclusion Participants must meet all the following criteria: * Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities * Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed * Resides in the United States * Has the opportunity for at least 30% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study * Exclusion Individuals who report any of the following during screening may be excluded from participation: * Report being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid US shipping address and mobile phone number * Reports current enrollment in another clinical trial * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Unable to read and understand English at a 7th grade level * Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk. * Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products * Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk * Lack of reliable daily access to the internet

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014-2605, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

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: Eligible participants must complete all enrollment procedures before stratification and randomization. During enrollment, participants will be stratified by sex assigned at birth (female or non-female), age (40-59 or 60+ years), and health outcome score, with score categories defined according to published PROMIS scoring guidelines. These stratification factors create 16 total strata to support balanced allocation across study groups. Participants will then be sequentially randomized within strata to ensure an equal distribution across each study product group. Following randomization, participants will receive their assigned study product along with an informational insert containing product usage instructions and study procedures.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 13, 2026
• Primary Completion (Estimated): August 13, 2027
• Study Completion (Estimated): August 13, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)