Firefighter Collaborative Research Project (FCRP)

The goal of this research is to test interventions to reduce firefighter cardiovascular, cognitive, and overall disease risks, including but not limited to risks associated with Per- and Polyfluorinated Substances (PFAS) exposure. Approximately 1,500 - 2,000 firefighters will be enrolled in the Fire Fighter Cancer Cohort Study (FFCCS). Among these individuals, those that express interest will then be screened for eligibility for the Firefighter Collaborative Research Project (FCRP) using information they provided for the Fire Fighter Cancer Cohort Study. Firefighters enrolled in the study will provide an initial blood sample and urine sample. The blood sample will be analyzed to determine the participant's PFAS levels. Based upon serum PFAS levels and responses from the screening survey, eligible participants will be randomly assigned into one of the following interventions: 1. Blood Donation, or Plasma Donation or Blood/Plasma Control Group; 2. Zone 2 Training or Zone 2 Control; 3. Intermittent Fasting or Intermittent Fasting Control. Individuals participating in the blood donation, plasma donation or blood/plasma control group would donate blood every 12 weeks, plasma every 6 weeks, or not donate blood or plasma. Participants in this intervention arm would continue this for a 12-month period. Individuals in the zone 2 training, zone 2 training control, intermittent fasting or intermittent fasting control group would participate in their intervention or control for a 4-month period. After 4 to 12 months participating in an intervention or control group, participants will be asked to provide a final urine sample and blood draw to determine if and to what degree their PFAS levels or other cardiovascular disease and other health risks have changed.

Study Overview

• Status: Recruiting
• Conditions: Exposure; Cardiopulmonary
• Intervention / Treatment: Behavioral: Blood Donation; Behavioral: Surveys; Behavioral: Plasma Donation; Behavioral: Zone 2 Training; Behavioral: Intermittent Fasting

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia Healy; Phone Number: (520) 626-3236; Email: healyo@arizona.edu
• Study Contact Backup: Name: Regan Conner; Email: rconner@catworks.arizona.edu

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Recruiting
      • Gilbert Fire & Rescue Department
      • Contact: David Switzer
    • Green Valley, Arizona, United States, 85622
      • Recruiting
      • Green Valley Fire
      • Contact: Chuck Wunder
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • University of Arizona
      • Contact: Shawn Beitel, MS
      • Contact: Olivia Healy
    • Tucson, Arizona, United States, 85701
      • Recruiting
      • Tucson Fire Department Headquarters
      • Contact: John Gulotta
    • Tucson, Arizona, United States, 85711
      • Recruiting
      • Tucson Fire Department Station 9
      • Contact: John Gulotta
    • Tucson, Arizona, United States, 85743
      • Recruiting
      • Northwest Fire District
      • Contact: Robert Corbell
    • Tucson, Arizona, United States, 85746
      • Recruiting
      • Drexel Heights Fire
      • Contact: Doug Chappell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • Active firefighter (including emergency medical responder and all firefighter subgroups) with either a volunteer or career status

  • Individual plans to remain in active service with their current agency for the next 2 years (not planning to retire or resign)
  • 18 years of age and older
  • Fluently speak and write in English
  • All genders, races, and ethnicities
  • Enrolled in the Fire Fighter Cancer Cohort Study (FFCCS) prior to enrolling in the Firefighter Collaborative Research Project (FCRP)
  • Complete a signed and dated informed consent document that indicates the participant has been informed of all aspects of the study prior to enrollment
  • Agree to avoid participating in FCRP intervention activities outside of their assigned intervention group for the duration of the study
  • Able to comply with scheduled visits, laboratory tests and other study procedures
  • BMI of 17.5 kg/m2 or greater and be greater than 115 pounds
  • Must also be eligible to donate blood and blood-based products if randomized into the blood or plasmapheresis intervention groups

Exclusion criteria from overall study:

• Not able to fluently speak or write in English
• Less than 18 years of age
• Currently a tobacco smoker or vaping (e.g. >2 cigarettes or cigars, or incidents of vaping in the past month)
• Those with planned travel or extended leave (e.g. >6 weeks) that would prevent their ability to participate in other interventions
• Those who are pregnant, breastfeeding, or have given birth within the past year
• Those with a history or diagnosis of any significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological disorders, severe injury or cancer that, in the opinion of the investigator, would potentially put the candidate at risk.

Exclusion criteria from blood or plasma donation intervention:

• Those from departments outside the state of Arizona
• Those with any medical contraindication (medical condition or medication) to blood donation
• Those that donated blood or plasma in the past three months
• Those knowing they have a condition indicative of levels of hemoglobin, hematocrit, red blood cells, or iron below the lower limit of normal levels

Exclusion criteria from the intermittent fasting intervention:

• Those from departments outside the state of Arizona
• Those with a history or diagnosis of diabetes, hypoglycemia thyroid disease, and/or an eating disorder
• Those who recently participated in intermittent fasting or Time Restricted Eating
• Those that recently used antidiabetic medication such as Semaglutide (sold as Ozempic, Wegovy, and Rybelsus) or Tirzepatide (sold as Mounjaro) for the treatment of type 2 diabetes or for weight loss will also be excluded from this group.
• Use of drugs that might affect intermittent fasting or eating behaviors

Exclusion from the zone-2 physical activity intervention:

• Currently participating in more than 90 minutes per week of aerobic, cardiovascular training (e.g. jogging, cycling, walking, swimming, HIIT) at >60% of their max heart rate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blood Donation	Behavioral: Blood Donation; Participants asked to donate whole blood at a donation facility from a list provided by the study.; Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.
Active Comparator: Plasma Donation	Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.; Behavioral: Plasma Donation; Participants asked to donate plasma at a donation facility from a list provided by the study.
Placebo Comparator: Blood/Plasma Control	Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.
Active Comparator: Zone 2 Training	Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.; Behavioral: Zone 2 Training; Participants asked to work out in their custom Zone 2 heart range 4 times a week for 45 to 60 minutes.
Active Comparator: Intermittent Fasting	Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.; Behavioral: Intermittent Fasting; Participants asked to engage in an intermittent fasting routine of a 16 hour fast followed by an 8 hour eating period at least 4 times a week.
Placebo Comparator: Zone 2 Control	Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.
Placebo Comparator: Intermittent Fasting Control	Behavioral: Surveys; Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in concentration of PFAS levels in serum	PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample	12 months
Change in epigenetic age	Epigenetic age is a mathematically derived age estimators that are based on combinations of methylation values that change with age at specific CpGs in the genome.	4 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Firefighters
• Other Study ID Numbers: FCRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No