AzTrials
AzTrials

ExposureFCRPNCT05869747

Firefighter Collaborative Research Project

A study testing Blood Donation, Plasma Donation and Zone 2 Training in people with Exposure and Cardiopulmonary, run by University of Arizona at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Exposure, Cardiopulmonary
What is being tested?
Blood Donation, Plasma Donation and Zone 2 Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,500 participants
Where
7 sitesUnited States
Study dates
22 Jun 2023to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Gilbert Fire & Rescue Department

    Gilbert, Arizona, 85295

  • Green Valley Fire

    Green Valley, Arizona, 85622

  • Tucson Fire Department Headquarters

    Tucson, Arizona, 85701

  • Tucson Fire Department Station 9

    Tucson, Arizona, 85711

  • University of Arizona

    Tucson, Arizona, 85719

  • Northwest Fire District

    Tucson, Arizona, 85743

  • Drexel Heights Fire

    Tucson, Arizona, 85746

Other trials in United States

About this study

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.

Being tested
Blood Donation, Plasma Donation, Zone 2 Training, Intermittent Fasting, Surveys
Keywords
Firefighters

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood DonationBehavioural

    Participants asked to donate whole blood at a donation facility from a list provided by the study.

  • Plasma DonationBehavioural

    Participants asked to donate plasma at a donation facility from a list provided by the study.

  • Zone 2 TrainingBehavioural

    Participants asked to work out in their custom Zone 2 heart range 4 times a week for 45 to 60 minutes.

  • Intermittent FastingBehavioural

    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.

  • SurveysBehavioural

    Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.

Study groups in NCT05869747
Study groupRoleWhat they receive
Blood DonationActive comparatorNot described
Receives: Behavioral: Blood Donation; Behavioral: Surveys
Plasma DonationActive comparatorNot described
Receives: Behavioral: Plasma Donation; Behavioral: Surveys
Blood/Plasma ControlPlacebo comparatorNot described
Receives: Behavioral: Surveys
Zone 2 TrainingActive comparatorNot described
Receives: Behavioral: Zone 2 Training; Behavioral: Surveys
Intermittent FastingActive comparatorNot described
Receives: Behavioral: Intermittent Fasting; Behavioral: Surveys
Zone 2 ControlPlacebo comparatorNot described
Receives: Behavioral: Surveys
Intermittent Fasting ControlPlacebo comparatorNot described
Receives: Behavioral: Surveys

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in concentration of PFAS levels in serum

    PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample

    Measured: 12 months

  2. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start22 Jun 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869747
Sponsor's protocol ID
FCRP
Acronym
FCRP
Status last verified
Jan 2025
First submitted
24 Apr 2023
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Conner R, Porter C, Lutrick K, Beitel SC, Hollister J, Healy O, Kern KJ, Wardenaar F, Gulotta JJ, Jack K, Huentelman M, Burgess JL, Furlong M. Interventions to Reduce Serum Per- and Poly-Fluoroalkyl Substances Levels, Improve Cardiovascular Risk Profiles, and Improve Epigenetic Age Acceleration in US Firefighters: Protocol for Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 16;14:e67120. doi: 10.2196/67120.

    PubMed 40239196

Questions about this trial

What is this clinical trial studying?

A study testing Blood Donation, Plasma Donation and Zone 2 Training in people with Exposure and Cardiopulmonary, run by University of Arizona at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in concentration of PFAS levels in serum (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05869747, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in