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Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes

Primary Purpose

Fatigue, Energy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Placebo Control Form 1
Energy Active Study Product 1.1 Usage
Energy Active Study Product 1.2 Usage
Energy Active Study Product 1.3 Usage
Sponsored by
Radicle Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults, 21 years of age and older 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 more energy as a primary desire Has the opportunity for at least 20% improvement in their primary health outcome score Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: Reports being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid US shipping address and mobile phone number 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 Reports current enrollment in another clinical trial Lack of reliable daily access to the internet Reports current use of chemotherapy or immunotherapy Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

Sites / Locations

  • Radicle Science, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo Control 1

Active Product 1.1

Active Product 1.2

Active Product 1.3

Arm Description

Energy Product Form 1 - control

Energy Product Form 1 - active product 1

Energy Product Form 1 - active product 2

Energy Product Form 1 - active product 3

Outcomes

Primary Outcome Measures

Change in fatigue
Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

Secondary Outcome Measures

Change in focus (cognitive function)
Mean difference in focus score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Change in sleep
Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance)
Change in feelings of anxiety
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where higher scores correspond to greater levels of anxiety)
Minimal clinically important difference (MCID) in fatigue
Likelihood of experiencing MCID in fatigue score as assessed by PROMIS Fatigue 8A
Minimal clinically important difference (MCID) in focus (cognitive function)
Likelihood of experiencing MCID in focus score as assessed by PROMIS Cognitive Function 4A
Minimal clinically important difference (MCID) in sleep
Likelihood of experiencing MCID in sleep score as assessed by PROMIS Sleep Disturbance 4A
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of experiencing MCID in anxiety score as assessed by PROMIS Anxiety 4A

Full Information

First Posted
October 3, 2023
Last Updated
October 23, 2023
Sponsor
Radicle Science
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1. Study Identification

Unique Protocol Identification Number
NCT06074627
Brief Title
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
Official Title
Radicle™ Energy2: A Parallel Group, Randomized, Double-Blinded, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Other Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
December 5, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radicle Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes
Detailed Description
This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for more energy, (2) have the opportunity for meaningful improvement in their health outcome score, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Energy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be stratified based on gender at birth, then randomized to one of the study arms
Masking
ParticipantInvestigator
Masking Description
Participants will be blinded to the product they receive.
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control 1
Arm Type
Placebo Comparator
Arm Description
Energy Product Form 1 - control
Arm Title
Active Product 1.1
Arm Type
Experimental
Arm Description
Energy Product Form 1 - active product 1
Arm Title
Active Product 1.2
Arm Type
Experimental
Arm Description
Energy Product Form 1 - active product 2
Arm Title
Active Product 1.3
Arm Type
Experimental
Arm Description
Energy Product Form 1 - active product 3
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy Placebo Control Form 1
Intervention Description
Participants will use their Radicle Energy Placebo Control Form 1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy Active Study Product 1.1 Usage
Intervention Description
Participants will use their Radicle Energy Active Study Product 1.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy Active Study Product 1.2 Usage
Intervention Description
Participants will use their Radicle Energy Active Study Product 1.2 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy Active Study Product 1.3 Usage
Intervention Description
Participants will use their Radicle Energy Active Study Product 1.3 as directed for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in fatigue
Description
Mean difference in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in focus (cognitive function)
Description
Mean difference in focus score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Time Frame
6 weeks
Title
Change in sleep
Description
Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4 to 20; where higher scores correspond to higher levels of sleep disturbance)
Time Frame
6 weeks
Title
Change in feelings of anxiety
Description
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where higher scores correspond to greater levels of anxiety)
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in fatigue
Description
Likelihood of experiencing MCID in fatigue score as assessed by PROMIS Fatigue 8A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in focus (cognitive function)
Description
Likelihood of experiencing MCID in focus score as assessed by PROMIS Cognitive Function 4A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in sleep
Description
Likelihood of experiencing MCID in sleep score as assessed by PROMIS Sleep Disturbance 4A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in feelings of anxiety
Description
Likelihood of experiencing MCID in anxiety score as assessed by PROMIS Anxiety 4A
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change in mood (emotional distress-depression)
Description
Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time Frame
6 weeks
Title
Change in libido
Description
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults, 21 years of age and older 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 more energy as a primary desire Has the opportunity for at least 20% improvement in their primary health outcome score Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: Reports being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid US shipping address and mobile phone number 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 Reports current enrollment in another clinical trial Lack of reliable daily access to the internet Reports current use of chemotherapy or immunotherapy Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager
Phone
760-281-3898
Email
studymgmt@radiclescience.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily K. Pauli, PharmD
Organizational Affiliation
Radicle Science, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radicle Science, Inc
City
Del Mar
State/Province
California
ZIP/Postal Code
92014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Management
Phone
760-281-3898
Email
studymgmt@radiclescience.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared with researchers outside of Radicle Collaborators on this study.
Links:
URL
http://radiclescience.com
Description
Radicle Science, Inc

Learn more about this trial

Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes

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