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

NCT ID: NCT07206979

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants completing pretest/baseline will be stratified based on their sex assignment at birth and age then randomized to one of the study groups sequentially based on all stratification measures collectively to ensure equal distribution to each study product group. Participants will be provided the study product and the study insert with instructions for use and study participation.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.

Study Groups

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Active Product 1

Hydration Active Product 1

Group Type EXPERIMENTAL

Hydration Active Product 1

Intervention Type DIETARY_SUPPLEMENT

Participants will use their Hydration Active Product 1 as directed for a period of 1 week.

Active Product 2

Hydration Active Product 2

Group Type EXPERIMENTAL

Hydration Active Product 2

Intervention Type DIETARY_SUPPLEMENT

Participants will use their Hydration Active Product 2 as directed for a period of 1 week.

Active Product 3

Hydration Active Product 3

Group Type EXPERIMENTAL

Hydration Active Product 3

Intervention Type DIETARY_SUPPLEMENT

Participants will use their Hydration Active Product 3 as directed for a period of 1 week.

Interventions

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Hydration Active Product 1

Participants will use their Hydration Active Product 1 as directed for a period of 1 week.

Intervention Type DIETARY_SUPPLEMENT

Hydration Active Product 2

Participants will use their Hydration Active Product 2 as directed for a period of 1 week.

Intervention Type DIETARY_SUPPLEMENT

Hydration Active Product 3

Participants will use their Hydration Active Product 3 as directed for a period of 1 week.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radicle Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Hewlings

Role: PRINCIPAL_INVESTIGATOR

Radicle Science

Locations

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Radicle Science Inc.

Del Mar, California, United States

Site Status

Countries

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United States

Central Contacts

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Study Manager

Role: CONTACT

858-779-0086

Susan Hewlings

Role: CONTACT

760-281-3898

Facility Contacts

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Study Manager

Role: primary

760-281-3898

Megan Mosely

Role: backup

Related Links

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Other Identifiers

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RADX_OL_2505_LIV

Identifier Type: -

Identifier Source: org_study_id

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