Radicle Health 25: A Study of Health and Wellness Products on Overall Health

NCT07039786 | Completed

• 1 other identifier: RADX-SP-2505_SR.1
• Study Type: interventional
• Target: 500
• 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; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)

  7 weeks

Secondary Outcomes (7)

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

  7 weeks

• Change in sexual health

  7 weeks

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

  7 weeks

• Change in mood (emotion distress-depression)

  7 weeks

• Minimal clinically important difference (MCID) in GI-related QOL

  7 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Radicle Health Placebo Control Product

Dietary Supplement: Placebo Control

Active Product

EXPERIMENTAL

Radicle Health Active Study Product

Dietary Supplement: Active Product

Interventions

Placebo Control DIETARY_SUPPLEMENT

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

Placebo Control

Active Product DIETARY_SUPPLEMENT

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

Active Product

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
• 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.
• 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
• 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 assigned sex 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: June 18, 2025
• First Posted: June 26, 2025
• Study Start: July 15, 2025
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)