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Health Interventions for Firefighter Cardiovascular Risk Reduction (FCRP Trial)
N/A
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
FCRP Trial Summary
This trial will study interventions to reduce cardiovascular, cognitive and overall disease risks in firefighters, including from PFAS exposure. 1500-2000 firefighters from Arizona will be screened for eligibility, then randomly assigned to one of 4 interventions. They will donate blood/plasma, do zone 2 training or intermittent fasting for 4-12 months, then have a final blood/urine test.
Who is the study for?
This trial is for active Arizona firefighters over 18, who plan to stay in service for the next 2 years and are part of the Fire Fighter Cancer Cohort Study. They must speak English fluently, have a BMI over 17.5 kg/m2, weigh more than 115 pounds, and be able to donate blood if needed. Smokers or those with significant health issues can't participate.Check my eligibility
What is being tested?
The study tests whether blood donation, plasma donation, Zone 2 Training (a type of exercise), or intermittent fasting can reduce cardiovascular disease risks and PFAS levels in firefighters. Participants will follow their assigned intervention for either four months or one year before retesting.See study design
What are the potential side effects?
Potential side effects may include discomfort at the blood draw site from donations; fatigue or physical strain from Zone 2 Training; hunger pangs during intermittent fasting; and general discomfort from participating in surveys.
FCRP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in concentration of PFAS levels in serum
Change in epigenetic age
FCRP Trial Design
7Treatment groups
Active Control
Placebo Group
Group I: Plasma DonationActive Control2 Interventions
Group II: Zone 2 TrainingActive Control2 Interventions
Group III: Intermittent FastingActive Control2 Interventions
Group IV: Blood DonationActive Control2 Interventions
Group V: Zone 2 ControlPlacebo Group1 Intervention
Group VI: Intermittent Fasting ControlPlacebo Group1 Intervention
Group VII: Blood/Plasma ControlPlacebo Group1 Intervention
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Who is running the clinical trial?
Arizona State UniversityOTHER
283 Previous Clinical Trials
108,014 Total Patients Enrolled
University of ArizonaLead Sponsor
515 Previous Clinical Trials
147,214 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have no health conditions or medications that prevent me from donating blood.My BMI is over 17.5 and I weigh more than 115 pounds.I am eligible to donate blood and blood products.I am not taking medications that affect my eating patterns.I do not have diabetes, thyroid issues, hypoglycemia, or an eating disorder.I have not used Semaglutide or Tirzepatide recently for diabetes or weight loss.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Zone 2 Control
- Group 2: Intermittent Fasting Control
- Group 3: Plasma Donation
- Group 4: Zone 2 Training
- Group 5: Intermittent Fasting
- Group 6: Blood Donation
- Group 7: Blood/Plasma Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently accepting participants for this experiment?
"The trial's records on clinicaltrials.gov reveal that it is accepting participants, with the initial posting taking place on June 22nd 2023 and being updated most recently on July 19th of this same year."
Answered by AI
How many participants are the researchers expecting to recruit for this experiment?
"Affirmative. According to the clinicaltrials.gov portal, this study is still enrolling participants and was initially posted on June 22nd 2023 with its most recent update being July 19th 2023. The research team requires 1200 volunteers across 7 different trial sites."
Answered by AI
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