NCT06212518

Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes

Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes: Phase 3b Multi-center Trial for Model Development

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: PepsiCo Global R&D · Industry
• Sex: All
• Age: 14 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 hydration status, including: 1) at various timepoints throughout a 24-hour period in healthy adults from the general population (GENPOP), and 2) before and after a team coach-led training session in athletes competing in a sport (ATHLETE). TOI data will be collected alongside standard reference measures of hydration status. In this study each subject will serve as their own control.

Conditions

• Dehydration

Interventions

Type	Name	Description
OTHER	GENPOP ad libitum fluid intake	Unrestricted fluid intake.
OTHER	GENPOP fluid restriction	In the 24 hours between the first and last face scan, reduce fluid intake by approximately 75% (equating to approximately 700 ml (women) and 800 ml (men)).
OTHER	ATHLETE ad libitum fluid intake	No restriction on fluid intake
OTHER	ATHLETE restricted fluid intake	Not permitted to drink during training session.

Timeline

• Start date: 2023-10-02
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

4 sites across 1 country: United States