NCT06044610

Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development

Utility of Transdermal Optical Imaging TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: PepsiCo Global R&D · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hypohydration from euhydration status including 1) a small feasibility study for 24-hour data collection in the general population using passive dehydration or ad libitum fluid intake (GENPOP), 2) an exercise study in moderately active participants in both dehydrated and euhydrated states (EXERCISE). TOI data will be collected alongside standard reference measures of hydration status. This is an exploratory pilot proof of concept study with each subject serving as their own control.

Conditions

• Dehydration

Interventions

Type	Name	Description
OTHER	GENPOP Passive dehydration (75% reduction in fluid intake	Over 24-hours
OTHER	GENPOP Ad lib fluid intake	Over 24 hours
OTHER	EXERCISE without fluid replacement	90-min standard cycling exercise trial in heat chamber
OTHER	EXERCISE with fluid replacement	90-min standard cycling exercise trial in heat chamber

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2023-09-21
• Last updated: 2024-01-19

Locations

2 sites across 1 country: United States