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

NCT06044610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-01-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • PepsiCo Global R&D

    lead INDUSTRY

Principal Investigators

  • Lindsay Baker, PhD · PepsiCo, Inc. Sports Science

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2023-11-15
Completion
2023-11-15

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06044610 on ClinicalTrials.gov