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Completed

NCT Number: NCT07117773

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

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.

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Key information

Conditions

Hydration Status

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gatorade Sports Science Institute

Bradenton, Florida, 34210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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.

    1=most dilute to 7= least dilute

  2. Body Weight

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

    (kg)

  3. Sweat Loss

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

    (mL) monitored using the Epicore Connected Hydration device

  4. Sweat Rate

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

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

  5. Sodium Concentrations

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

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

  6. Sodium Loss

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

    (g) monitored using the Epicore Connected Hydration device

  7. Fluid Intake

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

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

  8. 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.

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

  9. work-to-rest ratio

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

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

  10. 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

    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.

  11. Thirst

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

    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.

  12. Prior Night Sleep Quality

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

    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

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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