An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health

Radicle Science

Status: Not yet enrolling

Conditions: Hydration

Treatments: Dietary Supplement: Hydration Active Product 2; Dietary Supplement: Hydration Active Product 1; Dietary Supplement: Hydration Active Product 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT07206979

RADX_OL_2505_LIV

Details and patient eligibility

About

An Open Label Trial Assessing the Impact of a Hydration Formula on Overall Health

Full description

This is an open label study conducted with adult participants residing in the United States.

Eligible participants will (1) agree to consume a hydration product, (2) agree not to take any other hydration or electrolyte supplements for the duration of the trial, (3) be 21 years of age or older, and (4) agree to participate in this study for 2 week and answer assessments.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants over 2 weeks. Participant reports of health indicators will be collected at screening and throughout the active period of study product use. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Enrollment: 660 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

3.1 Inclusion

Participants must meet all the following criteria:

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races.
• Resides in the United States.

3.2 Exclusion

Individuals who report any of the following during screening will be excluded from participation:

• Report being pregnant, trying to become pregnant, or breastfeeding.

• Unable to provide a valid US shipping address and mobile phone number

• 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 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.

  • 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 the current use of electrolyte and/or hydration supplements that may limit the effects of the study products.

• Lack of reliable daily access to the internet.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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660 participants in 3 patient groups

Active Product 1

Experimental group

Description:

Hydration Active Product 1

Treatment:

Dietary Supplement: Hydration Active Product 1

Active Product 2

Experimental group

Description:

Hydration Active Product 2

Treatment:

Dietary Supplement: Hydration Active Product 2

Active Product 3

Experimental group

Description:

Hydration Active Product 3

Treatment:

Dietary Supplement: Hydration Active Product 3