Metabolomics of World Trade Center-Lung Injury: Biomarker Validation Assessment and Dietary Intervention Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Lung Injury
  • Age: Between 21 - 90 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are FDNY rescue and recovery worker
    2. Male subjects between the ages of 21 and 90 years old.
    3. Subjects with documented WTC exposure
    4. Subjects are willing and able to consent for themselves to study enrollment
    5. Subjects are willing and able to participate in study procedures
    6. Subjects are able to perform their activities of daily living independently
    7. Subjects are either light duty or retired FDNY Firefighters
    8. Subjects must have an FEV1 less than the LLN of predicted for age/sex/weight at any time point after 9/11/01
    9. Subjects must have a BMI>27 kg/m2 and <50kg/m2
    10. Subjects willing and able to modify their diet and activity level
    11. Subjects who have a spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.
    12. Subjects demonstrate minimal proficiency using a smart phone
    13. Subjects have means to accommodate transportation to/from in-person visits

You may not be eligible for this study if the following are true:

    1. Subjects have pre-existing and documented conditions or concurrent diagnoses, including (and not necessarily limited to) active cancer, severe heart disease, significant cognitive impairment, eating disorders, significant psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant.
    2. Subjects who have concomitant use of interfering medication(s) or devices currently or within the month prior to enrollment, including anti-retrovirals, human monoclonal antibodies, supplemental daytime oxygen, and insulin pumps.
    3. Subjects with severe gastrointestinal issues or illnesses that would prevent adherence to the proposed diets.
    4. Subjects with severe kidney disease requiring dialysis
    5. Subjects with severe liver disease requiring frequent medical intervention
    6. Subjects participating in other diet modification studies
    7. Subjects who have high dose steroid (>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation
    8. Subjects who have life-expectancy < 6 months
    9. Subjects with BMI ≥50 kg/m2 or ≤27 kg/m2
    10. Subjects who have recent significant intentional or unintentional weight loss, defined as over 5% reduction in total body weight over the last month. (Blackburn Criteria).
    11. Subjects who have significant or severe alcohol abuse disorder



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