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

NCT07802587 | Not Yet Recruiting

• 1 other identifier: RADX_P_2609_VKN
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

Radicle Performance™ VKN: 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

Outcome Measures

Primary Outcomes (1)

• Change in fatigue

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

  5 weeks

Secondary Outcomes (2)

• Change in sleep

  5 weeks

• Change in feelings of stress

  5 weeks

Other Outcomes (3)

• Minimal clinically important difference (MCID) in fatigue

  5 weeks

• Minimal clinically important difference (MCID) in sleep

  5 weeks

• Minimal clinically important difference (MCID) in feelings of stress

  5 weeks

Study Arms (2)

Active Health Performance Product 1

EXPERIMENTAL

Active Health Performance Product 1

Dietary Supplement: Active Health Performance Product

Placebo Health Performance Control

PLACEBO COMPARATOR

Placebo Health Performance Control

Dietary Supplement: Placebo Health Performance Control

Interventions

Placebo Health Performance Control DIETARY_SUPPLEMENT

Participants will use their Placebo Health Performance Control as directed for a period of 4 weeks

Placebo Health Performance Control

Active Health Performance Product DIETARY_SUPPLEMENT

Participants will use their Active Health Performance Product as directed for a period of 4 weeks

Active Health Performance Product 1

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

3.1 Inclusion Participants must meet all the following criteria: * Adults, aged 35-60 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 * Experiencing fatigue and/or perceiving a decline in sports performance due to tiredness * 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 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 * Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker collection. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the collection. No alternative collection pathway is available under the current protocol. * To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be presented with the biomarker collection consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the collection. These participants will otherwise proceed through full main study enrollment and participation without interruption.

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

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 requirements before stratification and randomization. Participants will be stratified using five factors: sex at birth (female or non-female), age (35-47 or 48-60 years), biospecimen collection participation (yes or no), aerobic exercise frequency (2-4 or 5+ times per week), and health outcome score (four levels based on PROMIS published scoring guidelines). These factors create 64 possible strata. Participants will then be sequentially randomized based on all stratification factors collectively to promote balanced distribution across study product groups. Following randomization, participants will receive their assigned study product along with an informational insert containing instructions for product use and additional study procedures.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)