Radicle HealthTM VIP: A Study Assessing the Impact of Health and Wellness Products on Metabolic Health and Related Health Outcomes

NCT07819110 | Not Yet Recruiting

• 1 other identifier: RADX_C_2605_VIP
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Health

Outcome Measures

Primary Outcomes (1)

• HbA1c Metabolic

  A metabolic test assessed by an at-home (direct-to-consumer) biospecimen (dried blood from a finger-prick) assay.

  27 weeks

Other Outcomes (3)

• Minimal clinically important difference in HbA1c metabolic

  27 weeks

• Wellbeing assessed by RAND SF-36

  27 weeks

• Blood glucose

  27 weeks

Study Arms (2)

Active Metabolic Product 1

EXPERIMENTAL

Active Metabolic Product 1

Dietary Supplement: Active Metabolic Product 1

Placebo Metabolic Control 1

PLACEBO COMPARATOR

Placebo Metabolic Control 1

Dietary Supplement: Placebo Metabolic Control 1

Interventions

Active Metabolic Product 1 DIETARY_SUPPLEMENT

Participants will use their Active Metabolic Product 1 as directed for a period of 24 weeks

Active Metabolic Product 1

Placebo Metabolic Control 1 DIETARY_SUPPLEMENT

Participants will use their Placebo Metabolic Control 1 as directed for a period of 24 weeks

Placebo Metabolic Control 1

Eligibility Criteria

• Age: 21 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 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 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. This may include: * 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. This may include: * 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

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 will complete all enrollment requirements before being stratified based on sex at birth, age, CGM collection participation, additional biomarker collection participation, and health outcome score. Participants will then be randomized sequentially to a study product group using all stratification factors collectively to support balanced distribution across groups. Following randomization, participants will receive their assigned study product along with instructions outlining product use and study procedures.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): September 17, 2027
• Study Completion (Estimated): September 17, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)