Metabolomics of World Trade Center-Lung Injury: Biomarker Validation, Longitudinal Assessment, and Dietary Intervention

Investigators propose to measure metabolites on this expanded cohort with serum sampled
before and after 6-month intervention with calorie restricted Mediterranean diet to: 1)
determine the effects of a technology assisted calorie restricted diet on metabolic risk and
lung function; 2) determine differences between usual care and intervention group using
genomics and metabolomics that may be targetable markers for further evaluation; 3) quantify
the metabolome and evaluate pre/post changes in BMI, FEV1, FeNo, vascular stiffness, and
overall quality of life; and 4) explore dietary modification as treatment of WTC-LI. The
biomarker profile of the cohort control will be useful for discovering biomarker associations
with other disease manifestations such as: bronchial wall thickening on CT, obstruction on
FEV1 /FVC ratio, bronchodilator response, methacholine reactivity, and other definitions of
loss of FEV 1 . This cohort control will be an asset to future studies.

Inclusion Criteria:

1. Age 21-90.

2. Born male sex and currently identify as genetic male

3. FDNY rescue and recovery worker.

4. Documented WTC exposure.

5. Enrolled in the FDNY WTC Health Program

6. Subjects are willing and able to consent for themselves to study enrollment

7. Subjects are willing and able to participate in study procedures

8. Are able to perform their activities of daily living independently

9. Are either light duty or retired FDNY Firefighters

10. Have an FEV1 less than the LLN of predicted for age/sex/weight within a year of
enrollment

11. Have a BMI>27 kg/m2 and <50kg/m2

12. Willing and able to modify their diet and activity level.

13. Spirometry available within the last 12 months, and at their first post-9/11 visit.

14. Demonstrate minimal proficiency using a smart phone

15. Have means to accommodate transportation to/from in-person visits

Exclusion Criteria:

1. 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. 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. Severe gastrointestinal issues or illnesses that would prevent adherence to the
proposed diets.

4. Severe kidney disease requiring dialysis

5. Severe liver disease requiring frequent medical intervention

6. Participating in other diet modification studies.

7. High dose steroid (>20mg prednisone or equivalent) or other hormonal
treatments/chemotherapy use in the last month, including testosterone supplementation.

8. Life-expectancy < 6 months

9. BMI ≥50 kg/m2 or ≤27 kg/m2

10. Recent significant intentional or unintentional weight loss, defined as over 5%
reduction in total body weight over the last month. (Blackburn Criteria).

11. Significant or severe alcohol abuse disorder