CClinicalTrials.gg
CompletedNCT07117773Updated Sep 12, 2025

Changes in Hydration Status of PepsiCo Frontline Workers in a Manufacturing Facility Over the Course of Multiple Shifts

An observational study in Hydration Status, sponsored by PepsiCo Global R&D. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by PepsiCo Global R&D · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hydration Status

Keywords

  • hydration
  • ergonomics
  • industrial worker
  • observational
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Frontline manufacturing and warehouse workers at Orlando PBNA Bottling Facility

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Subject has an allergy to adhesives
  • Female subject is pregnant or nursing
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Observational

    PepsiCo Frontline Workers

06

What researchers measure

Primary outcomes

  1. Acute Urine Specific Gravity

    USG digital pen refractometer (au)

    Time frame: Post-shift USG compared to pre-shift USG (8-12 hours from baseline) on consecutive test day 1-4 over calendar week.

  2. Chronic Urine Specific Gravity

    Digital pen refractometer (au)

    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.

Secondary outcomes

  1. Urine Color

    1=most dilute to 7= least dilute

    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.

  2. Body Weight

    (kg)

    Time frame: 15 minute pre- 8-12 hour shift on the first test day

  3. Sweat Loss

    (mL) monitored using the Epicore Connected Hydration device

    Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.

  4. Sweat Rate

    (mL/hr) monitored using the Epicore Connected Hydration device

    Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.

  5. Sodium Concentrations

    (g/L) monitored using the Epicore Connected Hydration device

    Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.

  6. Sodium Loss

    (g) monitored using the Epicore Connected Hydration device

    Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.

  7. Fluid Intake

    (g) pre-shift bottle weight before and after filled with water compared to pre- and post-refill bottle weight.

    Time frame: Each time water bottle is refilled over 8-12 hour shift, consecutive test day 1-4 over a calendar week.

  8. Measurment of physical activity and movement (Accelerometry)

    Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture.

    Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.

  9. work-to-rest ratio

    Assessed using the LifeBooster Senz devices. Device measures frequency and severity of movements and posture.

    Time frame: over the course of an 8-12 hour shift, consecutive test day 2-4 over a calendar week.

  10. 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.

    Time frame: 30 minutes pre- and 30 minutes post- 8-12 hour shift on consecutive test day 1-4, over a calendar week

  11. 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.

    Time frame: 30 minutes pre- and 30 minutes post- 8-12 hour shift on consecutive test day 1-4, over a calendar week

  12. 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

    Time frame: 30 minutes pre- 8-12 hour shift on consecutive test day 1-4, over a calendar week

07

Study locations

1 site
  • Gatorade Sports Science Institute
    Bradenton, Florida 34210, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07117773
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Aug 12, 2025
Start date
Aug 8, 2025
Primary completion
Aug 22, 2025
Completion
Aug 24, 2025
Last update
Sep 12, 2025

Study contacts

Philip Agostinelli, PhD
principal investigator · PepsiCo R&D/Gatorade and Sports Science Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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