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

Radicle Science

Status: Completed

Conditions: Energy; Fatigue

Treatments: Dietary Supplement: Energy Active Study Product 1.2 Usage; Dietary Supplement: Energy Placebo Control Form 1; Dietary Supplement: Energy Active Study Product 1.3 Usage; Dietary Supplement: Energy Active Study Product 1.1 Usage

Study type: Interventional

Funder types: Industry

Identifiers

NCT06074627

RADX-2304

Details and patient eligibility

About

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes

Full 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.

Enrollment: 1,189 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,189 participants in 4 patient groups, including a placebo group

Placebo Control 1

Placebo Comparator group

Description:

Energy Product Form 1 - control

Treatment:

Dietary Supplement: Energy Placebo Control Form 1

Active Product 1.1

Experimental group

Description:

Energy Product Form 1 - active product 1

Treatment:

Dietary Supplement: Energy Active Study Product 1.1 Usage

Active Product 1.2

Experimental group

Description:

Energy Product Form 1 - active product 2

Treatment:

Dietary Supplement: Energy Active Study Product 1.2 Usage

Active Product 1.3

Experimental group

Description:

Energy Product Form 1 - active product 3

Treatment:

Dietary Supplement: Energy Active Study Product 1.3 Usage