DehydrationNCT06044610

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

A study testing GENPOP Passive dehydration (75% reduction in fluid intake, GENPOP Ad lib fluid intake and EXERCISE without fluid replacement in people with Dehydration, run by PepsiCo Global R&D at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dehydration
What is being tested?: GENPOP Passive dehydration (75% reduction in fluid intake, GENPOP Ad lib fluid intake and EXERCISE without fluid replacement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: 8 May 2023to 15 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

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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

Who cannot join

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

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

PepsiCo R&D, Gatorade Sports Science Institute
Plano, Texas, 75024
PepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, 10595

Other trials in United States

About this study

Official title: 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.

Conditions: Dehydration
Being tested: GENPOP Passive dehydration (75% reduction in fluid intake, GENPOP Ad lib fluid intake, EXERCISE without fluid replacement, EXERCISE with fluid replacement
Keywords: hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging, TOI
Medical subject headings: Dehydration, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GENPOP Passive dehydration (75% reduction in fluid intakeOther
Over 24-hours
GENPOP Ad lib fluid intakeOther
Over 24 hours
EXERCISE without fluid replacementOther
90-min standard cycling exercise trial in heat chamber
EXERCISE with fluid replacementOther
90-min standard cycling exercise trial in heat chamber

Study groups in NCT06044610
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: EXERCISE with fluid replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

Transdermal optical imaging (TOI) signals
Blood flow patterns of the face obtained from the video camera on a smart phone
Measured: 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)
Measured: 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
Age, sex, ethnicity, race
Measured: At screening
Fitzpatrick scale
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.
Measured: At screening
Mood scale
9-point categorical scale from 1 (calm) to 9 (irritated)
Measured: 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
Log entries of food and drink
Measured: 24 hours prior to each visit through end of each study period.
EXERCISE only: Rate of perceived exertion (RPE)
Borg scale (6-20 scale) from no exertion at all to maximal exertion
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Heart rate
(beats/min)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Work rate
(watts, rpm)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Fluid intake (euhydrated state)
(fluid volume in milliliters)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Sweating rate
Rate of sweat over the course of the testing session.
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Biomechanical and physiological features associated with dehydration, fatigue, and energy
Measured on staff iPad or iPhone to extract facial movements \& voice quality features
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Physical and mental energy
Rated from 1=Energetic to 6= Worn out and from 1=Never to 5=Always.
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Grittiness score
8 item grit scale (examples: ideas, setbacks, goals)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Visual analogue scale for mental energy and fatigue
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)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Sweat biomarkers
(electrolyte and metabolites)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Saliva biomarkers
(osmolality and metabolites)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Fingertip capillary blood biomarkers
(electrolytes and osmolality)
Measured: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202315 Nov 2023

First posted21 Sep 2023
Study start8 May 2023
Primary completion15 Nov 2023
Study completion15 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DehydrationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06044610
Sponsor's protocol ID: PEP-2306 3a
Status last verified: Jan 2024
First submitted: 13 Sep 2023
Last updated: 19 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation

All Dehydration trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utility of Transdermal Optical Imaging TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
ClinicalTrials.gov ID: NCT06044610
Acronym / sponsor ID: PEP-2306 3a
Conditions: Dehydration
Keywords: hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging, TOI
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: PepsiCo Global R&DIndustry (pharma, biotech, devices)
Study start: 8 May 2023 (actual)
Primary completion: 15 Nov 2023 (actual)
Study completion: 15 Nov 2023 (actual)
First posted: 21 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an exploratory pilot proof of concept study with each subject serving as their own control.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
GENPOP passive dehydration	Experimental	Other: GENPOP Passive dehydration (75% reduction in fluid intake24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.
EXERCISE without fluid replacement	Experimental	Other: EXERCISE without fluid replacementRandomized 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.
GENPOP ad lib fluid intake	Other	Other: GENPOP Ad lib fluid intake24-hour data collection using a parallel design comparison of TOI blood flow patterns vs. reference methods of hydration status in 10 PEP employees.
EXERCISE with fluid replacement	Other	Other: EXERCISE with fluid replacementRandomized 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GENPOP Passive dehydration (75% reduction in fluid intakeOver 24-hours	Other	GENPOP passive dehydration
GENPOP Ad lib fluid intakeOver 24 hours	Other	GENPOP ad lib fluid intake
EXERCISE without fluid replacement90-min standard cycling exercise trial in heat chamber	Other	EXERCISE without fluid replacement
EXERCISE with fluid replacement90-min standard cycling exercise trial in heat chamber	Other	EXERCISE with fluid replacement

Primary outcome

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
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)

16 secondary outcomes

Demographics
Time frame: At screening
Fitzpatrick scale
Time frame: At screening
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
Dietary and fluid intake
Time frame: 24 hours prior to each visit through end of each study period.
EXERCISE only: Rate of perceived exertion (RPE)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Heart rate
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Work rate
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Fluid intake (euhydrated state)
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Sweating rate
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
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
EXERCISE only: Physical and mental energy
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Grittiness score
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
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
EXERCISE only: Sweat biomarkers
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Saliva biomarkers
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days
EXERCISE only: Fingertip capillary blood biomarkers
Time frame: Two 90 minute standard cycling exercise trials separated by approximately 3 to 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Individual participant dataSharing planned: No

Related trials for Dehydration

Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindsay Baker, PhD study director

PepsiCo, Inc. Sports Science

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06044610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.