Firefighter Collaborative Research Project (FCRP)

May 29, 2025 updated by: University of Arizona
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Gilbert Fire & Rescue Department
      • Green Valley, Arizona, United States, 85622
        • Green Valley Fire
      • Tucson, Arizona, United States, 85719
        • University of Arizona
      • Tucson, Arizona, United States, 85701
        • Tucson Fire Department Headquarters
      • Tucson, Arizona, United States, 85711
        • Tucson Fire Department Station 9
      • Tucson, Arizona, United States, 85743
        • Northwest Fire District
      • Tucson, Arizona, United States, 85746
        • Drexel Heights Fire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 sexes, 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 study for those outside of Arizona:

• Those with PFOS levels <5 ng/ml

Exclusion criteria from blood or plasma donation intervention:

  • 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 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
  • Those outside of the state of Arizona

Exclusion from the zone-2 physical activity intervention:

  • Currently participating in zone 2 physical activity training
  • Currently participating in more than 120 minutes per week of aerobic, cardiovascular training (e.g. jogging, cycling, walking, swimming, HIIT) at >60% of their max heart rate.
  • Those outside of the state of Arizona or in cities in Arizona where access to CPET testing is not possible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in concentration of PFAS levels in serum
Time Frame: 12 months
PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample
12 months
Change in epigenetic age
Time Frame: 4 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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