Radicle Relaxation™ 24_VNS: A Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes

NCT06999629 | Completed

• 1 other identifier: RADX-P-2408_VNS
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on stress and related health outcomes

Conditions

Stress

Outcome Measures

Primary Outcomes (2)

• Change in perceived stress

  Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)

  7 weeks

• Minimal clinical importance difference (MCID) in perceived stress

  Likelihood of achieving a MCID in perceived stress, as measured by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)

  7 weeks

Secondary Outcomes (6)

• Change in feelings of anxiety

  7 weeks

• Change in mood

  7 weeks

• Change in cognitive function

  7 weeks

• Minimal clinical importance difference (MCID) in cognitive function

  7 weeks

• Minimal clinical importance difference (MCID) in feelings of anxiety

  7 weeks

Other Outcomes (2)

• Change in sleep disturbance

  7 weeks

• Minimal clinical importance difference (MCID) in sleep disturbance

  7 weeks

Study Arms (3)

Placebo Control

PLACEBO COMPARATOR

Relaxation Product Form - Control

Dietary Supplement: Relaxation Placebo Control

Active Product 1

EXPERIMENTAL

Relaxation Product Form - Active 1

Dietary Supplement: Relaxation Active Product 1

Active Product 2

EXPERIMENTAL

Relaxation Product Form - Active 2

Dietary Supplement: Relaxation Active Product 2

Interventions

Relaxation Placebo Control DIETARY_SUPPLEMENT

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

Placebo Control

Relaxation Active Product 1 DIETARY_SUPPLEMENT

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

Active Product 1

Relaxation Active Product 2 DIETARY_SUPPLEMENT

Participants will use their Relaxation Active Product 2 as directed for a period of 6 weeks.

Active Product 2

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 o 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.
• 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 and/or pose a known safety risk
• 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: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 3, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)