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

Not Applicable

Not yet recruiting

• Conditions: Hydration

• Registration Number: NCT07206979
• Lead Sponsor: Radicle Science

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study Start: 2025-09-30
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hydration: Differences in self-reported perceptions of hydration	2 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Energy: Differences in self-reported perceptions of energy	2 weeks	Energy; Differences in self-reported perceptions of energy as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of energy).
Jitters: Differences in self-reported perceptions of jitters	2 weeks	Jitters; Differences in self-reported perceptions of jitters as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of jitters)
Focus; Differences in self-reported perceptions of focus	2 weeks	Focus; Differences in self-reported perceptions of focus as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of focus)
Productivity: Differences in self-reported perceptions of productivity	2 weeks	Productivity; Differences in self-reported perceptions of productivity as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of productivity)
Confidence: Differences in self-reported perceptions of confidence	2 weeks	Confidence; Differences in self-reported perceptions of confidence as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of confidence).
Interest in Socializing: Differences in self-reported perceptions of socialization	2 weeks	Interest in Socializing; Differences in self-reported perceptions of socialization as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of socialization)
Feeling Rested: Differences in self-reported perceptions of restfulness	2 weeks	Feeling Rested; Differences in self-reported perceptions of restfulness as assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater feelings of being rested)
Quality of Sleep: Differences in self-reported perceptions of sleep quality	2 weeks	Quality of Sleep; Differences in self-reported perceptions of sleep quality assessed by an item assessing perceptions of hydration (scale 1-5; where higher scores correspond to greater quality of sleep)

Trial Locations

Locations (1)

Radicle Science Inc.; 🇺🇸 Del Mar, California, United States