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

NCT07206979 | Not Yet Recruiting

• 1 other identifier: RADX_OL_2505_LIV
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hydration

Outcome Measures

Primary Outcomes (1)

• Hydration: Differences in self-reported perceptions of hydration

  Hydration; Differences in self-reported perceptions of hydration as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of hydration)

  2 weeks

Secondary Outcomes (8)

• Energy: Differences in self-reported perceptions of energy

  2 weeks

• Jitters: Differences in self-reported perceptions of jitters

  2 weeks

• Focus; Differences in self-reported perceptions of focus

  2 weeks

• Productivity: Differences in self-reported perceptions of productivity

  2 weeks

• Confidence: Differences in self-reported perceptions of confidence

  2 weeks

Study Arms (3)

Active Product 1

EXPERIMENTAL

Hydration Active Product 1

Dietary Supplement: Hydration Active Product 1

Active Product 2

EXPERIMENTAL

Hydration Active Product 2

Dietary Supplement: Hydration Active Product 2

Active Product 3

EXPERIMENTAL

Hydration Active Product 3

Dietary Supplement: Hydration Active Product 3

Interventions

Hydration Active Product 1 DIETARY_SUPPLEMENT

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

Active Product 1

Hydration Active Product 2 DIETARY_SUPPLEMENT

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

Active Product 2

Hydration Active Product 3 DIETARY_SUPPLEMENT

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

Active Product 3

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Manager

CONTACT

858-779-0086; studymgmt@radiclescience.com

Susan Hewlings

CONTACT

760-281-3898; susan.hewlings@radiclescience.com

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: 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.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)