DehydrationNCT06212518

Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes

A study testing GENPOP ad libitum fluid intake, GENPOP fluid restriction and ATHLETE ad libitum fluid intake in people with Dehydration, run by PepsiCo Global R&D at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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 hydration status, including: 1) at various timepoints throughout a 24-hour period in healthy adults from the general population (GENPOP), and 2) before and after a team… Read more about this study

Who is it for?: Ages 14 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dehydration
What is being tested?: GENPOP ad libitum fluid intake, GENPOP fluid restriction and ATHLETE ad libitum fluid intake
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 4 sitesUnited States
Study dates: 2 Oct 2023to 31 Aug 2024
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 14 to 65 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Both Study Arms (GENPOP and ATHLETE)
Subject is male or female
If female, subject is not pregnant
Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
Subject is willing to avoid wearing makeup to the study session or willing to remove it with facial wipes before the face scans
Subject is willing to shave facial hair if predetermined during the informed consent session it will interfere with TOI measurement

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Able to speak, write, and read English
Provision of written consent to participate
GENPOP Study
Study subject is 18-65 years of age, inclusive
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 fast overnight (~8-12 hours)
Subject is willing to refrain from vigorous exercise for 48 hours
Subject is willing to eat the exact same food the day prior to each visit to the testing site
ATHLETE Study
Study subject is 14-45 years of age, inclusive
Subject is participating in team sport training/competition
Subject is participating in a coach-led practice

Who cannot join

Both Study Arms (GENPOP and ATHLETE)
Subject has participated or currently enrolled 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 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.
GENPOP Study
Subject has a health condition or is taking medication that can be worsened by fluid restriction (participants who opt-in to fluid restriction study arm only)

Trial locations and contacts

4 sites in 1 country.

Matthew Hinkley, PhD contact

914-742-4975

Matt.Hinkley@pepsico.com

United States4 sites, 4 recruiting

Pepsico R&D Life Sciences
Bradenton, Florida, 34210
Khalil Lee, PhD, 334-728-0250, khalil.Lee@pepsico.com
Matthew Hinkley, PhD, 914-742-4975, Matt.Hinkley@pepsico.com
Recruiting
PepsiCo R&D Gatorade Sports Science Institute
Chicago, Illinois, 60607
Shellen Goltz, PhD, 312-821-3317, Shellen.Goltz@pepsico.com
Matthew Hinkley, PhD, 914-742-4975, Matt.Hinkley@pepsico.com
Recruiting
PepsiCo R&D, Gatorade Sports Science Institute
Plano, Texas, 75024
Anthony Wolfe, MS, 469-920-2862, Anthony.Wolfe@pepsico.com
Matthew Hinkley, PhD, 914-742-4975, Matt.Hinkley@pepsico.com
Recruiting
PepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, 10595
Matthew Hinkley, PhD, 914-742-4975, Matt.Hinkley@pepsico.com
Matthew Hinkley, PhD
Recruiting

Other trials in United States

About this study

Official title: Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes: Phase 3b Multi-center Trial for Model Development

In this study each subject will serve as their own control.

Conditions: Dehydration
Being tested: GENPOP ad libitum fluid intake, GENPOP fluid restriction, ATHLETE ad libitum fluid intake, ATHLETE restricted fluid intake
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 ad libitum fluid intakeOther
Unrestricted fluid intake.
GENPOP fluid restrictionOther
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)).
ATHLETE ad libitum fluid intakeOther
No restriction on fluid intake
ATHLETE restricted fluid intakeOther
Not permitted to drink during training session.

Study groups in NCT06212518
Study group	Role	What they receive
GENPOP passive dehydration	Experimental	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. Receives: Other: GENPOP fluid restriction
GENPOP ad libitum fluid intake	Experimental	No fluid restriction Receives: Other: GENPOP ad libitum fluid intake
ATHLETE with fluid restriction	Experimental	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. Receives: Other: ATHLETE restricted fluid intake
ATHLETE ad libitum fluid intake	Experimental	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. Receives: Other: ATHLETE ad libitum fluid intake

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: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Standard measurement of hydration status: Body mass change
Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
Measured: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Standard measurements of hydration status: Urine specific gravity
Digital pen refractometer (Atago, PEN-Urine SG)
Measured: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Standard measurements of hydration status: Urine color
Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7
Measured: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Standard measurements of hydration status: Thirst
Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty
Measured: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise

Secondary outcomes (7)

Subject demographics - Age
in years
Measured: At screening
Subject demographics - Sex
male or female
Measured: At screening
Subject demographics - Ethnicity
Hispanic or Latino, or not Hispanic or Latino
Measured: At screening
Subject demographics - Race
American Indian, Alaska native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White
Measured: At screening
Fitzpatrick classification of skin color
Skin type from 1=White skin, always burns, never tans to 6 = Black skin, heavily pigmented, never burns, tans very easily
Measured: At screening
Mood scale
Rated from 1=Calm to 9=Irritated
Measured: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Dietary and fluid intake
Food and fluid intake recorded on a paper log
Measured: For GENPOP from 24 hours prior to Day 1 visit (~8 a.m.) through end of testing period (Day 2 ~8 a.m.). For ATHLETES from 24 hours to prior to start of single ~45 minute exercise session (if fluid restricted) or to end of exercise (if ad lib fluid intake)

Timeline

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

2 Oct 202331 Aug 2024

First posted19 Jan 2024
Study start2 Oct 2023
Primary completion31 Aug 2024 (estimated)
Study completion31 Aug 2024 (estimated)

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: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06212518
Sponsor's protocol ID: PEP-2306 3b
Status last verified: Jan 2024
First submitted: 14 Dec 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?

Matthew Hinkley, PhD

914-742-4975

Matt.Hinkley@pepsico.com

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: Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes: Phase 3b Multi-center Trial for Model Development
ClinicalTrials.gov ID: NCT06212518
Acronym / sponsor ID: PEP-2306 3b
Conditions: Dehydration
Keywords: hydration, dehydration, euhydration, hypohydration, exercise, Transdermal Optical Imaging, TOI
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,000 participants (estimated)
Lead sponsor: PepsiCo Global R&DIndustry (pharma, biotech, devices)
Study start: 2 Oct 2023 (actual)
Primary completion: 31 Aug 2024 (estimated)
Study completion: 31 Aug 2024 (estimated)
First posted: 19 Jan 2024 (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.

In this study each subject will serve as their own control.

Study design

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

Arm	Type	Receives
GENPOP passive dehydration	Experimental	Other: GENPOP fluid restrictionIn 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.
GENPOP ad libitum fluid intake	Experimental	Other: GENPOP ad libitum fluid intakeNo fluid restriction
ATHLETE with fluid restriction	Experimental	Other: ATHLETE restricted fluid intakeFor 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.
ATHLETE ad libitum fluid intake	Experimental	Other: ATHLETE ad libitum fluid intakeFor 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.

Who may qualify

Ages: 14 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

Both Study Arms (GENPOP and ATHLETE)
Subject is male or female
If female, subject is not pregnant
Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
Subject is willing to avoid wearing makeup to the study session or willing to remove it with facial wipes before the face scans

Key exclusion criteria (8 listed)

Both Study Arms (GENPOP and ATHLETE)
Subject has participated or currently enrolled 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

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 ad libitum fluid intakeUnrestricted fluid intake.	Other	GENPOP ad libitum fluid intake
GENPOP fluid restrictionIn 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)).	Other	GENPOP passive dehydration
ATHLETE ad libitum fluid intakeNo restriction on fluid intake	Other	ATHLETE ad libitum fluid intake
ATHLETE restricted fluid intakeNot permitted to drink during training session.	Other	ATHLETE with fluid restriction

Primary outcome

Transdermal Optical Imaging (TOI) signals
Time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Blood flow patterns of the face obtained from the video camera on a smart phone
Standard measurement of hydration status: Body mass change
Time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Body mass scale (Tanita, WB-800 Plus) to the nearest 0.01 kilogram (kg)
Standard measurements of hydration status: Urine specific gravity
Time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Digital pen refractometer (Atago, PEN-Urine SG)
Standard measurements of hydration status: Urine color
Time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, upon arrival before a single ~45 minute exercise training session and again immediately after exercise
Color range scale rated from dilute to concentrated. 1=clear through yellows and oranges with most orange =7
Standard measurements of hydration status: Thirst
Time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Categorical scale from 1=Not thirsty at all, to 7=very, very thirsty

7 secondary outcomes

Subject demographics - Age
Time frame: At screening
Subject demographics - Sex
Time frame: At screening
Subject demographics - Ethnicity
Time frame: At screening
Subject demographics - Race
Time frame: At screening
Fitzpatrick classification of skin color
Time frame: At screening
Mood scale
Time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise
Dietary and fluid intake
Time frame: For GENPOP from 24 hours prior to Day 1 visit (~8 a.m.) through end of testing period (Day 2 ~8 a.m.). For ATHLETES from 24 hours to prior to start of single ~45 minute exercise session (if fluid restricted) or to end of exercise (if ad lib fluid intake)

Results and safety

Results are not available in the source record.

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)
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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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.

Matthew Hinkley, PhD contact

914-742-4975

Matt.Hinkley@pepsico.com

Lindsay Baker, PhD study director

PepsiCo, Inc. Sports Science

Matt Hinkley, PhD principal investigator

Pepsico, Inc. Sports Science

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

Questions about this trial

What is this clinical trial studying?

A study testing GENPOP ad libitum fluid intake, GENPOP fluid restriction and ATHLETE ad libitum fluid intake in people with Dehydration, run by PepsiCo Global R&D at 4 sites in United States.

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 20 inclusion and 8 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: status not confirmed, 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 4 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?

Results are not available in the source record.

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

Contact Matthew Hinkley, PhD (914-742-4975, Matt.Hinkley@pepsico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transdermal Optical Imaging (TOI) signals (time frame: Four time points for GENPOP over 24 hours (Day 1 ~8 a.m., ~11:30 a.m., ~3:30 p.m., Day 2 ~8.a.m.; for ATHLETES, on arrival before a single ~45 minute exercise training session and immediately following a 30 minute cool down period post-exercise). The study lists 5 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 NCT06212518.

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.