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

NCT07653724 | Not Yet Recruiting

• 1 other identifier: RADX_P_2604_VBM
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.

Conditions

Fatigue; Cognitive Function; Global Mental Health; Sleep Disturbance

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)

  7 weeks

Secondary Outcomes (3)

• Change in cognitive function

  7 weeks

• Change in Global Mental Health

  7 weeks

• Change in sleep

  7 weeks

Other Outcomes (6)

• Minimal clinically important difference (MCID) in fatigue

  7 weeks

• Minimal clinically important difference (MCID) in cognitive function

  7 weeks

• Minimal clinically important difference (MCID) in Global Mental Health

  7 weeks

Study Arms (2)

Active Energy Product 1

EXPERIMENTAL

Energy Active Product 1

Dietary Supplement: Energy Active Product 1

Placebo Energy Control

PLACEBO COMPARATOR

Energy Product Placebo Control

Dietary Supplement: Energy Product Placebo Control

Interventions

Energy Product Placebo Control DIETARY_SUPPLEMENT

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

Placebo Energy Control

Energy Active Product 1 DIETARY_SUPPLEMENT

Participants will use their Energy Active Product 1 as directed for a period of 6 weeks.

Active Energy Product 1

Eligibility Criteria

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

Participants must meet all the following criteria: * Adults, at least 21 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 3.2 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 caffeine-alternative products * Reports consuming 3 or more caffeinated beverages a day * 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, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fatigue; Parasomnias

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

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 steps to be stratified. Participants will be stratified based on their age, sex assignment at birth, and health outcome score during enrollment, then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and an insert with additional information on product usage and study procedures.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)