Hydration StatusNCT07117773
Changes in Hydration Status of PepsiCo Frontline Workers in a Manufacturing Facility Over the Course of Multiple Shifts
An observational study of Hydration Status, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
Physically demanding occupations (PDO) require high levels of energy expenditure, mental acuity, and technical skills. Sometimes this work is 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
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 24 Aug 2025
- Phase
- Observational
- 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
Study population: Frontline manufacturing and warehouse workers at Orlando PBNA Bottling Facility
Who may be able to join
- Self-identify as a healthy male or female
- Subject is 18-65 years of age
- The subject is currently employed by PepsiCo at a bottling facility
- Subject can read and comprehend English
- Subject has worked for PepsiCo for 2 months or longer
- Willing to agree with what is outlined in the informed consent form.
Who cannot join
- Subject has an allergy to adhesives
- Female subject is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Gatorade Sports Science Institute
Bradenton, Florida, 34210
About this study
Physically demanding occupations (PDO) require high levels of energy expenditure, mental acuity, and technical skills. Sometimes this work is performed in extreme environments during hot/humid summer months. Previous research shows that dehydration and heat stress can increase risk of heat-related illness, reduced cognitive function, and work capacity. While this impact of physically demanding work in extreme environmental conditions is often studied in firefighters, military personnel, and athletes, and even agricultural workers, manufacturing and warehouse workers ("the industrial athlete") are underrepresented in the literature.
The purpose of the study is to examine the impact hydration status of the industrial athlete (i.e., frontline manufacturing and warehouse workers at PepsiCo facilities) prior to, during, and after their shift over a typical work week has on work performance.
Note: Recruitment is limited to PepsiCo Frontline Employees Only. Do not contact study official for enrollment.
- Conditions
- Hydration Status
- Keywords
- hydration, ergonomics, industrial worker, observational
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.
Acute Urine Specific Gravity
USG digital pen refractometer (au)
Measured: Post-shift USG compared to pre-shift USG (8-12 hours from baseline) on consecutive test day 1-4 over calendar week.
Chronic Urine Specific Gravity
Digital pen refractometer (au)
Measured: pre- and post- 8-12 hour shift USG on the last test day compared to pre- and post-8-12 hour shift USGs at baseline. Over 4 consecutive test days during a calendar week.
Secondary outcomes (12)
Urine Color
1=most dilute to 7= least dilute
Measured: 15 minutes pre- 9-12 hour shift and 15 minutes post- 8-12 hour shift, consecutive test day 1-4 over a calendar week.
Body Weight
(kg)
Measured: 15 minute pre- 8-12 hour shift on the first test day
Sweat Loss
(mL) monitored using the Epicore Connected Hydration device
Measured: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Sweat Rate
(mL/hr) monitored using the Epicore Connected Hydration device
Measured: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Sodium Concentrations
(g/L) monitored using the Epicore Connected Hydration device
Measured: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Sodium Loss
(g) monitored using the Epicore Connected Hydration device
Measured: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Fluid Intake
(g) pre-shift bottle weight before and after filled with water compared to pre- and post-refill bottle weight.
Measured: Each time water bottle is refilled over 8-12 hour shift, consecutive test day 1-4 over a calendar week.
Measurment of physical activity and movement (Accelerometry)
Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture.
Measured: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
work-to-rest ratio
Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture.
Measured: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
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: 30 minutes pre- and 30 minutes post- 8-12 hour shift on consecutive test day 1-4, over a calendar week
Thirst
Visual Analog Scale- 6 questions: 4 questions are anchored from not at all or none to very, and 2 questions are anchored from pleasant to unpleasant.
Measured: 30 minutes pre- and 30 minutes post- 8-12 hour shift on consecutive test day 1-4, over a calendar week
Prior Night Sleep Quality
Pittsburgh Sleep Quality Index (PSQI). Measures sleep quality through seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. Score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: 30 minutes pre- 8-12 hour shift on consecutive test day 1-4, over a calendar week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start8 Aug 2025
- Primary completion22 Aug 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration StatusStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Agostinelli, PhD, Principal investigator, PepsiCo R&D/Gatorade and Sports Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117773
- Sponsor's protocol ID
- PEP-2509
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Hydration Status of PepsiCo Frontline Workers in a Manufacturing Facility Over the Course of Multiple Shifts
- ClinicalTrials.gov ID
- NCT07117773
- Acronym / sponsor ID
- PEP-2509
- Conditions
- Hydration Status
- Keywords
- hydration, ergonomics, industrial worker, observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 12 Aug 2025 (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 (PDO) require high levels of energy expenditure, mental acuity, and technical skills. Sometimes this work is performed in extreme environments during hot/humid summer months. Previous research shows that dehydration and heat stress can increase risk of heat-related illness, reduced cognitive function, and work capacity. While this impact of physically demanding work in extreme environmental conditions is often studied in firefighters, military personnel, and athletes, and even agricultural workers, manufacturing and warehouse workers ("the industrial athlete") are underrepresented in the literature.
The purpose of the study is to examine the impact hydration status of the industrial athlete (i.e., frontline manufacturing and warehouse workers at PepsiCo facilities) prior to, during, and after their shift over a typical work week has on work performance.
Note: Recruitment is limited to PepsiCo Frontline Employees Only. Do not contact study official for enrollment.
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
- Frontline manufacturing and warehouse workers at Orlando PBNA Bottling Facility
Key inclusion criteria (6 listed)
- Self-identify as a healthy male or female
- Subject is 18-65 years of age
- The subject is currently employed by PepsiCo at a bottling facility
- Subject can read and comprehend English
- Subject has worked for PepsiCo for 2 months or longer
Key exclusion criteria (2 listed)
- Subject has an allergy to adhesives
- Female subject is pregnant or nursing
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
Acute Urine Specific Gravity
Time frame: Post-shift USG compared to pre-shift USG (8-12 hours from baseline) on consecutive test day 1-4 over calendar week.
USG digital pen refractometer (au)
Chronic Urine Specific Gravity
Time frame: pre- and post- 8-12 hour shift USG on the last test day compared to pre- and post-8-12 hour shift USGs at baseline. Over 4 consecutive test days during a calendar week.
Digital pen refractometer (au)
12 secondary outcomes
Urine Color
Time frame: 15 minutes pre- 9-12 hour shift and 15 minutes post- 8-12 hour shift, consecutive test day 1-4 over a calendar week.
Body Weight
Time frame: 15 minute pre- 8-12 hour shift on the first test day
Sweat Loss
Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Sweat Rate
Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Sodium Concentrations
Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Sodium Loss
Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Fluid Intake
Time frame: Each time water bottle is refilled over 8-12 hour shift, consecutive test day 1-4 over a calendar week.
Measurment of physical activity and movement (Accelerometry)
Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
work-to-rest ratio
Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.
Mental and Physical Energy and Fatigue
Time frame: 30 minutes pre- and 30 minutes post- 8-12 hour shift on consecutive test day 1-4, over a calendar week
Thirst
Time frame: 30 minutes pre- and 30 minutes post- 8-12 hour shift on consecutive test day 1-4, over a calendar week
Prior Night Sleep Quality
Time frame: 30 minutes pre- 8-12 hour shift on consecutive test day 1-4, over a calendar week
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 12 Sep 2025.
- Individual participant dataSharing planned: No
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Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
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Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
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Not yet recruiting
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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.
Philip Agostinelli, PhD principal investigator
PepsiCo R&D/Gatorade and Sports Science Institute
1 site 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, run by PepsiCo Global R&D at 1 site 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 6 inclusion and 2 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Acute Urine Specific Gravity (time frame: Post-shift USG compared to pre-shift USG (8-12 hours from baseline) on consecutive test day 1-4 over calendar week.). 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?
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 12 Sep 2025.