Hydration Status and Ergonomic Risk in Frontline WorkersNCT07848256
Hydration, Ergonomic Risk, and Fatigue Across Multiple PepsiCo Facilities
An observational study of Hydration Status and Ergonomic Risk in Frontline Workers, run by PepsiCo Global R&D at 2 sites in United States.
Trial summary
Physically demanding occupations require high levels of energy expenditure, mental sharpness, and technical skills, and are often performed in extreme environments during hot/humid summer months. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status and Ergonomic Risk in Frontline Workers
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Self-identified healthy male and female PepsiCo employees between the ages of 18-65 who have been employed at their location for 2 months or longer.
Who may be able to join
- Participant self-identifies as a healthy male or female
- Participant is 18-65 years of age
- Participant has worked for their employer for at least 2 months
- Participant is willing to agree to the protocol outlined in the informed consent form
Who cannot join
- Participant has an allergy to adhesives
- Female participant is pregnant or nursing
- Optional Core Temperature Pill Monitoring exclusion:
- You have a known or suspected obstructive disease of the gastrointestinal (GI) tract
- You have a disordered gag reflex
- You have had a previous GI surgery
Show all 10Show fewer
- You have felinization of the esophagus
- You have hypomotility disorders of the GI tract
- You have a cardiac pacemaker or other implanted electromedical devices
- You might undergo MRI scanning during the period the ingested capsule was within the body
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Orlando PBNA Bottling Facility
Orlando, Florida, 32809
PepsiCo Beverages
Tampa, Florida, 33612
About this study
Physically demanding occupations require high levels of energy expenditure, mental sharpness, and technical skills, and are often performed in extreme environments during hot/humid summer months. Previous research shows dehydration and heat stress can increase risk of heat-related illness, reduce cognitive function, and work capacity. The relationship between hydration status and occupational physical and environmental demands has yet to be fully understood and compared across occupations. This study will examine hydration, sweat profile, activity level and its association with ergonomic risk (high, moderate, and mild risk movement patterns performed during work) and fatigue to improve our understanding of the hydration needs of warehouse workers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | PepsiCo Frontline Workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Balance
Fluid Intake (mL) - sweat losses (mL)
Measured: Day 1, over 8-12 hour shift
Urine Color
1=most dilute to 7= least dilute, with higher scores associated with a dehydration and a poorer outcome.
Measured: Day 1, 15 minutes pre- 8-12 hour shift and 15 minutes post- 8-12 hour shift
Internal Workload
Average Heart Rate (beats per minute)
Measured: Day 1, over 8-12 hour shift
Ergonomic Risk
Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture
Measured: Day 1, over 8-12 hour shift
Self-reported Changes in Fatigue
Mental and Physical Energy and Fatigue. Visual Analog Scale (VAS): 6 questions to describe capacity for physical activity anchored from No to Strongest Feelings and 6 questions describe capacity for mental activity anchored from No to Strongest Feelings.
Measured: Day 1, 15 minutes pre- and 15 minutes post- 8-12 hour shift
Secondary outcomes (10)
Sweat Rate
(mL/hr) monitored using the Epicore Connected Hydration device
Measured: Day 1, over an 8-12 hour shift
Sweat Sodium Concentration
(g/L) monitored using the Epicore Connected Hydration device
Measured: Day 1, over an 8-12 hour shift
Fluid Intake
(g) pre-shift bottle weight before and after filled with water compared to pre- and post-refill bottle weight.
Measured: Day 1, Each time water bottle is refilled over 8-12 hour shift
Urine Specific Gravity
USG digital pen refractometer (au)
Measured: Day 1, Post-shift USG compared to pre-shift USG (8-12 hours from baseline)
Estimated Energy Expenditure
estimated based on an equation using heart rate (HR), age (years), sex (male or female), and body mass (kg).
Measured: Day 1, over 8-12 hour shift
Core Temperature
Optional. Measured by digital core temperature monitoring pill ingested pre-shift (Celsius).
Measured: over 8-12 hour shift
Environmental Conditions
Temperature (Celsius)
Measured: Day 1, pre-, mid-, and post-shift over 8-12 hour shift.
Environmental Conditions
Humidity (%)
Measured: Day 1, pre-, mid-, and post-shift over 8-12 hour shift.
Environmental Conditions
wet bulb globe temperature (Celsius) measured using a portable heat stress monitor.
Measured: Day 1, pre-, mid-, and post-shift over 8-12 hour shift.
Adverse Events
Documented changes in health and symptoms
Measured: Through study completion, an average of 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration Status and Ergonomic Risk in Frontline WorkersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korey Stringer Institute, EpiCore Biosystems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848256
- Sponsor's protocol ID
- PEP-2608
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration, Ergonomic Risk, and Fatigue Across Multiple PepsiCo Facilities
- ClinicalTrials.gov ID
- NCT07848256
- Acronym / sponsor ID
- PEP-2608
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Collaborators
- Korey Stringer Institute, EpiCore Biosystems
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
Physically demanding occupations require high levels of energy expenditure, mental sharpness, and technical skills, and are often performed in extreme environments during hot/humid summer months. Previous research shows dehydration and heat stress can increase risk of heat-related illness, reduce cognitive function, and work capacity. The relationship between hydration status and occupational physical and environmental demands has yet to be fully understood and compared across occupations. This study will examine hydration, sweat profile, activity level and its association with ergonomic risk (high, moderate, and mild risk movement patterns performed during work) and fatigue to improve our understanding of the hydration needs of warehouse workers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –PepsiCo Frontline Workers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Self-identified healthy male and female PepsiCo employees between the ages of 18-65 who have been employed at their location for 2 months or longer.
Key inclusion criteria (4 listed)
- Participant self-identifies as a healthy male or female
- Participant is 18-65 years of age
- Participant has worked for their employer for at least 2 months
- Participant is willing to agree to the protocol outlined in the informed consent form
Key exclusion criteria (10 listed)
- Participant has an allergy to adhesives
- Female participant is pregnant or nursing
- You have a known or suspected obstructive disease of the gastrointestinal (GI) tract
- You have a disordered gag reflex
- You have had a previous GI surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fluid Balance
Time frame: Day 1, over 8-12 hour shift
Fluid Intake (mL) - sweat losses (mL)
Urine Color
Time frame: Day 1, 15 minutes pre- 8-12 hour shift and 15 minutes post- 8-12 hour shift
1=most dilute to 7= least dilute, with higher scores associated with a dehydration and a poorer outcome.
Internal Workload
Time frame: Day 1, over 8-12 hour shift
Average Heart Rate (beats per minute)
Ergonomic Risk
Time frame: Day 1, over 8-12 hour shift
Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture
Self-reported Changes in Fatigue
Time frame: Day 1, 15 minutes pre- and 15 minutes post- 8-12 hour shift
Mental and Physical Energy and Fatigue. Visual Analog Scale (VAS): 6 questions to describe capacity for physical activity anchored from No to Strongest Feelings and 6 questions describe capacity for mental activity anchored from No to Strongest Feelings.
10 secondary outcomes
Sweat Rate
Time frame: Day 1, over an 8-12 hour shift
Sweat Sodium Concentration
Time frame: Day 1, over an 8-12 hour shift
Fluid Intake
Time frame: Day 1, Each time water bottle is refilled over 8-12 hour shift
Urine Specific Gravity
Time frame: Day 1, Post-shift USG compared to pre-shift USG (8-12 hours from baseline)
Estimated Energy Expenditure
Time frame: Day 1, over 8-12 hour shift
Core Temperature
Time frame: over 8-12 hour shift
Environmental Conditions
Time frame: Day 1, pre-, mid-, and post-shift over 8-12 hour shift.
Environmental Conditions
Time frame: Day 1, pre-, mid-, and post-shift over 8-12 hour shift.
Environmental Conditions
Time frame: Day 1, pre-, mid-, and post-shift over 8-12 hour shift.
Adverse Events
Time frame: Through study completion, an average of 1 day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydration Status and Ergonomic Risk in Frontline Workers, run by PepsiCo Global R&D at 2 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 4 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fluid Balance (time frame: Day 1, over 8-12 hour shift). 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?
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 29 Sep 2026.