Radicle Health 24: A Study of Health and Wellness Products on Overall Health

NCT06989710 | Completed

• 1 other identifier: RADX-P-2405
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on overall health

Conditions

Overall Health

Outcome Measures

Primary Outcomes (1)

• Change in overall health Profile

  Difference between rates of change over time in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr consists of 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognitive function abilities; PROPr t-score score range = -.022 to 1; higher scores indicate greater overall health)

  7 weeks

Secondary Outcomes (9)

• Minimal clinical importance difference (MCID) in overall health-related quality of life

  7 weeks

• Change in sexual health - female

  7 weeks

• Change in sexual health - male

  7 weeks

• Change in GI-related Quality of Life (QOL)

  7 weeks

• Change in mood (emotion distress-depression)

  7 weeks

Study Arms (5)

Placebo control 7.1.0

PLACEBO COMPARATOR

Health product 7.1.0 - control

Dietary Supplement: Placebo control 7.1.0

Active product 7.1.1

EXPERIMENTAL

Health product 7.1.1 - active product 1

Dietary Supplement: Health Active Product 7.1.1 usage

Active product 7.1.2

EXPERIMENTAL

Health product 7.1.2 - active product 2

Dietary Supplement: Health Active Product 7.1.2 usage

Placebo control 7.2.0

PLACEBO COMPARATOR

Health product 7.2.0 - control

Dietary Supplement: Placebo control 7.2.0

Active product 7.2.1

EXPERIMENTAL

Health product 7.2.1 - active product 1

Dietary Supplement: Health Active Product 7.2.1 usage

Interventions

Placebo control 7.1.0 DIETARY_SUPPLEMENT

Participants will use their placebo control 7.1.0 as directed for a period of 6 weeks.

Placebo control 7.1.0

Health Active Product 7.1.1 usage DIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 7.1.1 as directed for a period of 6 weeks.

Active product 7.1.1

Health Active Product 7.1.2 usage DIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 7.1.2 as directed for a period of 6 weeks.

Active product 7.1.2

Placebo control 7.2.0 DIETARY_SUPPLEMENT

Participants will use their placebo control 7.2.0 as directed for a period of 6 weeks.

Placebo control 7.2.0

Health Active Product 7.2.1 usage DIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 7.2.1 as directed for a period of 6 weeks.

Active product 7.2.1

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, 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 surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses better overall health as a primary desire
• 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

You may not qualify if:

• 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
• 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.
• o 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.
• o 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
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014-2605, United States

Location

Related Links

• Radicle Science, Inc

Study Officials

• Susan Hewlings

  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' 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: Participants will be stratified based on their gender assigned at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 25, 2025
• Study Start: May 2, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)