NCT07117773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 8, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

14 days

First QC Date

August 5, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

hydrationergonomicsindustrial workerobservational

Outcome Measures

Primary Outcomes (2)

  • Acute Urine Specific Gravity

    USG digital pen refractometer (au)

    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)

    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

    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

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

  • Sweat Loss

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

  • Sweat Rate

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

  • Sodium Concentrations

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

  • +7 more secondary outcomes

Study Arms (1)

Observational

PepsiCo Frontline Workers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Frontline manufacturing and warehouse workers at Orlando PBNA Bottling Facility

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gatorade Sports Science Institute

Bradenton, Florida, 34210, United States

Location

Study Officials

  • Philip Agostinelli, PhD

    PepsiCo R&D/Gatorade and Sports Science Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

August 8, 2025

Primary Completion

August 22, 2025

Study Completion

August 24, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations