Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

NCT05589948 | Completed

• 1 other identifier: RADX-22D04
• Study Type: interventional
• Target: 1,211
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress and other health outcomes

Conditions

Anxiety; Stress

Outcome Measures

Primary Outcomes (1)

• Change in feelings of anxiety

  Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)

  4 weeks

Secondary Outcomes (5)

• Minimal clinically important difference (MCID) in anxiety

  4 weeks

• Change in stress

  4 weeks

• Minimal clinically important difference (MCID) in stress

  4 weeks

• Change in sleep disturbance

  4 weeks

• Change in cognitive function

  4 weeks

Other Outcomes (2)

• Change in mood (emotional distress)

  4 weeks

• Change in libido

  4 weeks

Study Arms (5)

Placebo Control 1

PLACEBO COMPARATOR

Calm Product Form 1 - control

Dietary Supplement: Radicle Calm Study Placebo Control 1

Placebo Control 2

PLACEBO COMPARATOR

Calm Product Form 2 - control

Dietary Supplement: Radicle Calm Study Placebo Control 2

Active Product 1.1

EXPERIMENTAL

Calm Product Form 1 - active product 1

Dietary Supplement: Radicle Calm Study Active Product 1.1

Active Product 2.1

EXPERIMENTAL

Calm Product Form 2 - active product 1

Dietary Supplement: Radicle Calm Study Active Product 2.1

Active Product 2.2

EXPERIMENTAL

Calm Product Form 2 - active product 2

Dietary Supplement: Radicle Calm Study Active Product 2.2

Interventions

Radicle Calm Study Placebo Control 1 DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.

Placebo Control 1

Radicle Calm Study Placebo Control 2 DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.

Placebo Control 2

Radicle Calm Study Active Product 1.1 DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.

Active Product 1.1

Radicle Calm Study Active Product 2.1 DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.

Active Product 2.1

Radicle Calm Study Active Product 2.2 DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.

Active Product 2.2

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, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress)
• Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
• 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:

• Pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid physical shipping address
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Lack of reliable daily access to the internet
• Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs (monoamine oxidase inhibitors)
• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

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 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 gender at birth then randomized to one of the study arms

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: October 10, 2022
• Primary Completion: May 3, 2023
• Study Completion: August 15, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)