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

NCT06044610 | Completed

• 1 other identifier: PEP-2306 3a
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

hydration; dehydration; euhydration; hypohydration; exercise; Transdermal Optical Imaging; TOI

Outcome Measures

Primary Outcomes (2)

• Transdermal optical imaging (TOI) signals

  Blood flow patterns of the face obtained from the video camera on a smart phone

  GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise session allowing for 30 minute cool down period.

• Standard measurements of hydration status

  Body mass change, urine specific gravity, urine color (1-8 scale), and visual analogue scale to indicate thirst (1=not thirsty at all to 7 very, very thirsty)

  GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day. For EXERCISE, pre and post exercise sessions allowing for 30 minute cool down period.

Secondary Outcomes (16)

• Demographics

  At screening

• Fitzpatrick scale

  At screening

• Mood scale

  GENPOP: Before breakfast (~ 8 a.m.), before lunch ~11:30 a.m.), ~3:30 p,m., ~8.a.m. the following day

• Dietary and fluid intake

  24 hours prior to each visit through end of each study period.

• EXERCISE only: Rate of perceived exertion (RPE)

  Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days

Study Arms (4)

GENPOP passive dehydration

EXPERIMENTAL

24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.

Other: GENPOP Passive dehydration (75% reduction in fluid intake

EXERCISE without fluid replacement

EXPERIMENTAL

Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst.

Other: EXERCISE without fluid replacement

GENPOP ad lib fluid intake

OTHER

24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.

Other: GENPOP Ad lib fluid intake

EXERCISE with fluid replacement

OTHER

Randomized cross-over design in 15 moderately active non-employee participants. 90 minutes of standard cycling exercise trial in heat chamber. TOI signals will obtain blood flow patterns from the face to compare against reference methods of dehydration including body mass, urine specific gravity, urine color, and thirst.

Other: EXERCISE with fluid replacement

Interventions

GENPOP Passive dehydration (75% reduction in fluid intake OTHER

Over 24-hours

GENPOP passive dehydration

GENPOP Ad lib fluid intake OTHER

Over 24 hours

GENPOP ad lib fluid intake

EXERCISE without fluid replacement OTHER

90-min standard cycling exercise trial in heat chamber

EXERCISE without fluid replacement

EXERCISE with fluid replacement OTHER

90-min standard cycling exercise trial in heat chamber

EXERCISE with fluid replacement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• For GENPOP, subject is willing to refrain from vigorous exercise for 48 hours
• For EXERCISE, subject is willing to refrain from vigorous exercise for 24 hours prior to study visits
• Subject is willing to eat the exact same food the day prior to each visit to the laboratory
• Subject is willing to avoid wearing makeup to the study session
• Subject is willing to shave facial hair if predetermined during the informed consent session it will interfere with TOI measurement

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (2)

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, 10595, United States

Location

PepsiCo R&D, Gatorade Sports Science Institute

Plano, Texas, 75024, United States

Location

MeSH Terms

Conditions

Dehydration; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lindsay Baker, PhD

  PepsiCo, Inc. Sports Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: May 8, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)