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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

NCT06044610•PepsiCo Global R&D

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is male or female
•If female, subject is not pregnant
•For GENPOP study subject is 18-65 years of age, inclusive
•For EXERCISE study subject is 18-50 years of age, inclusive
•Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 1 hour at a time (EXERCISE session participants only)
•Subject does not smoke (or has quit for at least 6 months)
•Subject is not taking medication that may interfere with the study
•Subject has no health conditions that would prevent completion of the trial as indicated on the general health questionnaire (GHQ)
•Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
•Subject is willing to fast overnight (\~8-12 hours)
+7 more criteria

Exclusion Criteria

•Subject has participated in a clinical trial within the past 30 days
•Subject has participated in any PepsiCo trial within past 6 months
•Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
•Subject is allergic to alcohol or facial cleansing wipes
•Subject has a history of anaphylaxis or severe allergic reactions
•Subjects has a health condition or is taking medication that can be worsened by fluid restriction
•Subject has asthma or other condition which breathing can become labored during exercise (EXERCISE session participants only)
•Male subjects with a VO2max \< 42 ml/kg/min and females with a VO2max \< 38 ml/kg/min (EXERCISE session participants only)
•Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Locations (2)

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, United States

PepsiCo R&D, Gatorade Sports Science Institute

Plano, Texas, United States

Key Dates

Start Date

May 8, 2023

Primary Completion Date

November 15, 2023

Completion Date

November 15, 2023

Last Updated

January 19, 2024

Enrollment

ACTUAL participants

Conditions

Dehydration

Interventions

GENPOP Passive dehydration (75% reduction in fluid intake

OTHER

GENPOP Ad lib fluid intake

OTHER

EXERCISE without fluid replacement

OTHER

EXERCISE with fluid replacement

OTHER

Point of Care Ultrasound and Co-loading in Patients With Spinal-induced Hypotension and Cardiac Diseases

NCT06206434

Fluid TherapyDehydration

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RECRUITINGNA

Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students

NCT06259799

Dehydration

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Point of Care Ultrasound and Co-loading in Patients With Spinal-induced Hypotension and Cardiac Diseases

Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students

Effects of Hydration Changes on Neuromuscular Function of Athletes

GEL-AID: Safe and Effective Hydration for Institutionalized Older Adults

Rehydration With a Trace Mineral Supplement

Effect of a Mobile-Based Hydration Tracking Program on Knowledge, Attitudes, and Behaviors in Older Adults