What side effects are associated with this type of intervention?

Common treatments for dehydration include oral rehydration solutions (ORS), intravenous (IV) fluids, and electrolyte supplements. ORS can sometimes cause mild gastrointestinal discomfort, such as nausea or bloating. IV fluids, while effective, may lead to complications like infection at the injection site, phlebitis, or fluid overload if not monitored properly. Electrolyte supplements can occasionally cause imbalances if not administered correctly. Non-invasive techniques like Transdermal Optical Imaging (TOI) are being studied to assess hydration status without these risks, offering a safer alternative for monitoring and potentially guiding treatment.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals or related drugs for the treatment of dehydration, nor does it detail non-invasive techniques similar to Smartphone-based Transdermal Optical Imaging (TOI). Generally, FDA-approved treatments for dehydration include oral rehydration solutions (ORS) and intravenous fluids, which are used to replenish lost fluids and electrolytes. These treatments are well-established and commonly used in clinical practice to manage dehydration.

What other types of research exist?

Promising, novel alternatives to Smartphone-based Transdermal Optical Imaging (TOI) for assessing hydration status in dehydration patients include: 1) Near-Infrared Spectroscopy (NIRS), which measures tissue oxygenation and hydration levels; 2) Bioelectrical Impedance Analysis (BIA), which estimates body composition and fluid status; and 3) Wearable sensors that continuously monitor physiological parameters such as skin conductance and temperature, providing real-time hydration status.

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Transdermal Optical Imaging for Dehydration

N/A

Recruiting

Led By Matt Hinkley, PhD

Research Sponsored by PepsiCo Global R&D

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If female, subject is not pregnant

ATHLETE Study: Study subject is 14-45 years of age, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at screening

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a smartphone app to measure skin hydration in healthy adults and athletes. The app works by shining light on the skin and analyzing the reflection to see how hydrated you are.

Who is the study for?

This trial is for healthy adults and athletes who want to help test a new way of measuring hydration using a smartphone app. Participants will either limit their fluid intake or drink as much as they want, at different times over 24 hours or around a sports training session.

What is being tested?

The study is testing Transdermal Optical Imaging (TOI) technology in two groups: general population and athletes. It aims to see if the TOI can accurately tell how hydrated someone is by comparing it with standard methods, during normal activities and after exercise.

What are the potential side effects?

Since this trial involves non-invasive monitoring with a smartphone app and changes in water consumption, there are no direct side effects from any medication or intervention being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant.

Select...

I am between 14 and 45 years old.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Standard measurement of hydration status: Body mass change

Standard measurements of hydration status: Thirst

Standard measurements of hydration status: Urine color

+2 more

Secondary study objectives

Dietary and fluid intake

Fitzpatrick classification of skin color

Mood scale

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: GENPOP passive dehydrationExperimental Treatment1 Intervention

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)). Participants will be provided pre-filled water bottles and asked to only ingest fluid in bottle until second morning face scan.

Group II: GENPOP ad libitum fluid intakeExperimental Treatment1 Intervention

No fluid restriction

Group III: ATHLETE with fluid restrictionExperimental Treatment1 Intervention

For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Not permitted to drink during training session.

Group IV: ATHLETE ad libitum fluid intakeExperimental Treatment1 Intervention

For 24 hours prior to the study session, encouraged to drink sufficient fluid to maintain euhydration. Asked to refrain from alcohol 24 hours prior to session. Permitted to drink during training session.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dehydration include oral rehydration solutions (ORS), intravenous (IV) fluids, and electrolyte replacement. ORS works by utilizing a precise balance of salts and sugars to enhance water absorption in the intestines. IV fluids quickly restore fluid balance and electrolytes directly into the bloodstream, which is crucial for severe dehydration. Electrolyte replacement ensures the proper function of cells and organs. Monitoring hydration status is vital for dehydration patients to prevent complications, and non-invasive techniques like Transdermal Optical Imaging (TOI) offer a promising way to assess hydration levels accurately and conveniently, potentially improving patient outcomes.

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