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

Recruiting

• Conditions: Hydration Status

• Registration Number: NCT07117773
• Lead Sponsor: PepsiCo Global R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Study Start: 2025-08-08
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-08-24
• Study Completion: 2025-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Urine Specific Gravity	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	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 Outcome Measures

Name	Time	Method
Body Weight	15 minute pre- 8-12 hour shift on the first test day	(kg)
Sodium Loss	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
Fluid Intake	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.
Measurment of physical activity and movement (Accelerometry)	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.
work-to-rest ratio	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.
Mental and Physical Energy and Fatigue	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.
Thirst	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.
Urine Color	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
Sweat Rate	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
Sodium Concentrations	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
Sweat Loss	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
Prior Night Sleep Quality	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

Trial Locations

Locations (1)

Gatorade Sports Science Institute; 🇺🇸 Bradenton, Florida, United States