Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes

NCT06378801 | Completed

• 1 other identifier: RADX-P-2408
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Change in stress

  Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)

  6 weeks

Secondary Outcomes (7)

• Change in feelings of anxiety

  6 weeks

• Change in cognitive function

  6 weeks

• Change in mood (emotional distress-depression)

  6 weeks

• Minimal clinically important difference (MCID) in stress

  6 weeks

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

  6 weeks

Other Outcomes (1)

• Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool

  6 weeks

Study Arms (9)

Placebo Control 1

PLACEBO COMPARATOR

Relaxation Product Form 1 - control

Dietary Supplement: Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

Relaxation Product Form 1 - active product 1

Dietary Supplement: Relaxation Active Study Product 1.1

Placebo Control 2

PLACEBO COMPARATOR

Relaxation Product Form 2 - control

Dietary Supplement: Placebo Control Form 2

Active Product 2.1

EXPERIMENTAL

Relaxation Product Form 2 - active product 1

Dietary Supplement: Relaxation Active Study Product 2.1

Placebo Control 3

PLACEBO COMPARATOR

Relaxation Product Form 3 - control

Dietary Supplement: Placebo Control Form 3

Active Product 3.1

EXPERIMENTAL

Relaxation Product Form 3 - active product 1

Dietary Supplement: Relaxation Active Study Product 3.1

Placebo Control 4

PLACEBO COMPARATOR

Relaxation Product Form 4 - control

Dietary Supplement: Placebo Control Form 4

Active Product 4.1

EXPERIMENTAL

Relaxation Product Form 4 - active product 1

Dietary Supplement: Relaxation Active Study Product 4.1

Active Product 4.2

EXPERIMENTAL

Relaxation Product Form 4 - active product 2

Dietary Supplement: Relaxation Active Study Product 4.2

Interventions

Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1

Relaxation Active Study Product 1.1 DIETARY_SUPPLEMENT

Participants will use their Radicle Relaxation Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Placebo Control Form 2 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.

Placebo Control 2

Relaxation Active Study Product 2.1 DIETARY_SUPPLEMENT

Participants will use their Radicle Relaxation Active Study Product 2.1 as directed for a period of 6 weeks.

Active Product 2.1

Placebo Control Form 3 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.

Placebo Control 3

Relaxation Active Study Product 3.1 DIETARY_SUPPLEMENT

Participants will use their Radicle Relaxation Active Study Product 3.1 as directed for a period of 6 weeks.

Active Product 3.1

Placebo Control Form 4 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.

Placebo Control 4

Relaxation Active Study Product 4.1 DIETARY_SUPPLEMENT

Participants will use their Radicle Relaxation Active Study Product 4.1 as directed for a period of 6 weeks.

Active Product 4.1

Relaxation Active Study Product 4.2 DIETARY_SUPPLEMENT

Participants will use their Radicle Relaxation Active Study Product 4.2 as directed for a period of 6 weeks.

Active Product 4.2

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 and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or 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 less stress as a primary desire
• Has the opportunity for at least 20% 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:

• Reports 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 (New York Heart Association) Class Ill 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, MAOls (monoamine oxidase inhibitors), or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

Study Officials

• Emily K. Pauli, PharmD

  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' study product assignment. Participants are blinded to the study product they are assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on gender at birth, then randomized to one of the study arms

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 22, 2024
• Study Start: February 29, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)