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Completed

NCT Number: NCT06044610

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PepsiCo R&D, Gatorade Sports Science Institute, Valhalla, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • 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
  • Able to speak, write, and read English
  • Provision of written consent to participate

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.

Treatment and study plan

GENPOP Passive dehydration (75% reduction in fluid intake

Other

Over 24-hours

GENPOP Ad lib fluid intake

Other

Over 24 hours

EXERCISE without fluid replacement

Other

90-min standard cycling exercise trial in heat chamber

EXERCISE with fluid replacement

Other

90-min standard cycling exercise trial in heat chamber

Primary outcomes

  1. Transdermal optical imaging (TOI) signals

    Time frame: 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.

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

  2. Standard measurements of hydration status

    Time frame: 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.

    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)

Secondary outcomes

  1. Demographics

    Time frame: At screening

    Age, sex, ethnicity, race

  2. Fitzpatrick scale

    Time frame: At screening

    Classification of skin type 1 through 6, 1=White skin. Always burns, never tans, to 6=Black skin. Heavily pigmented. Never burns, tans very easily.

  3. Mood scale

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

    9-point categorical scale from 1 (calm) to 9 (irritated)

  4. Dietary and fluid intake

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

    Log entries of food and drink

  5. EXERCISE only: Rate of perceived exertion (RPE)

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

    Borg scale (6-20 scale) from no exertion at all to maximal exertion

  6. EXERCISE only: Heart rate

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

    (beats/min)

  7. EXERCISE only: Work rate

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

    (watts, rpm)

  8. EXERCISE only: Fluid intake (euhydrated state)

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

    (fluid volume in milliliters)

  9. EXERCISE only: Sweating rate

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

    Rate of sweat over the course of the testing session.

  10. EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy

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

    Measured on staff iPad or iPhone to extract facial movements & voice quality features

  11. EXERCISE only: Physical and mental energy

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

    Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always.

  12. EXERCISE only: Grittiness score

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

    8 item grit scale (examples: ideas, setbacks, goals)

  13. EXERCISE only: Visual analogue scale for mental energy and fatigue

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

    Marked on a horizontal line anchored by 0-100 mm with 0 (no energy and fatigue) to 100 mm (strongest feeling of energy and strongest feeling of fatigue ever felt)

  14. EXERCISE only: Sweat biomarkers

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

    (electrolyte and metabolites)

  15. EXERCISE only: Saliva biomarkers

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

    (osmolality and metabolites)

  16. EXERCISE only: Fingertip capillary blood biomarkers

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

    (electrolytes and osmolality)

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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