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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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)
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- 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.
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- 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
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.
- Conditions
- Exposure, Cardiopulmonary
- 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 group | Role | What they receive |
|---|---|---|
| Blood Donation | Active comparator | Not described Receives: Behavioral: Blood Donation; Behavioral: Surveys |
| Plasma Donation | Active comparator | Not described Receives: Behavioral: Plasma Donation; Behavioral: Surveys |
| Blood/Plasma Control | Placebo comparator | Not described Receives: Behavioral: Surveys |
| Zone 2 Training | Active comparator | Not described Receives: Behavioral: Zone 2 Training; Behavioral: Surveys |
| Intermittent Fasting | Active comparator | Not described Receives: Behavioral: Intermittent Fasting; Behavioral: Surveys |
| Zone 2 Control | Placebo comparator | Not described Receives: Behavioral: Surveys |
| Intermittent Fasting Control | Placebo comparator | Not described Receives: Behavioral: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of PFAS levels in serum
PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start22 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Firefighter Collaborative Research Project
- ClinicalTrials.gov ID
- NCT05869747
- Acronym / sponsor ID
- FCRP / FCRP
- Conditions
- Exposure, Cardiopulmonary
- Keywords
- Firefighters
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Blood Donation | Active comparator | Behavioral: Blood Donation, Behavioral: Surveys |
| Plasma Donation | Active comparator | Behavioral: Plasma Donation, Behavioral: Surveys |
| Blood/Plasma Control | Placebo comparator | Behavioral: Surveys |
| Zone 2 Training | Active comparator | Behavioral: Zone 2 Training, Behavioral: Surveys |
| Intermittent Fasting | Active comparator | Behavioral: Intermittent Fasting, Behavioral: Surveys |
| Zone 2 Control | Placebo comparator | Behavioral: Surveys |
| Intermittent Fasting Control | Placebo comparator | Behavioral: Surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DonationParticipants asked to donate whole blood at a donation facility from a list provided by the study. | Behavioural | Blood Donation |
| Plasma DonationParticipants asked to donate plasma at a donation facility from a list provided by the study. | Behavioural | Plasma Donation |
| Zone 2 TrainingParticipants asked to work out in their custom Zone 2 heart range 4 times a week for 45 to 60 minutes. | Behavioural | Zone 2 Training |
| Intermittent FastingParticipants 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. | Behavioural | Intermittent Fasting |
| SurveysParticipants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. | Behavioural | Blood Donation, Blood/Plasma Control, Intermittent Fasting, Intermittent Fasting Control, Plasma Donation, Zone 2 Control, Zone 2 Training |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 40239196Conner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
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.