Clinical trial NCT03581006: Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
Official title: Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Injury
Particulate Matter Inhalation Injury
Keywords: World Trade Center
Firefighters
FDNY
9/11
Metabolomics
FIREHOUSE
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry criteria.

Brief summary: This is a randomized-controlled unblinded clinical trial to investigate dietary intervention on metabolic biomarker assessment in World Trade Center (WTC) Lung Injury (LI) in firefighters. The purpose of this study is to evaluate biomarkers of metabolic dysregulation that have previously been found to predict WTC-LI in a case cohort study selected from the entire exposed firefighter cohort, and attempt to alter these metabolites using dietary intervention and a technology-supported behavioral modification program. Investigators will measure Pre/Post global metabolic expression in WTC-exposed, symptomatic firefighter serum sampled after 6-month intervention, as well as clinical outcomes of WTC-LI in the study group vs controls.

Detailed description: 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.

Eligibility criteria: 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 documented at any time after 9/11/2001.
11. Have a BMI\>27 kg/m2 and \<50kg/m2
12. Willing and able to modify their diet and activity level.
13. Subjects who have a spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY
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

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: 4 Years
Secondary outcomes:
measure: Pulmonary Function using FEV Measure
timeFrame: 4 Years
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 4 Years
measure: Electrocardiogram (EKG)
timeFrame: 4 years
measure: Fraction of exhaled nitrous oxide (FENO)
timeFrame: 4 years
measure: Pulse Wave Velocity (PWV)
timeFrame: 4 years
measure: Individual microbiome profile - stool sample
timeFrame: 4 years
measure: 6-minute walk test (6MWT)
timeFrame: 4 years
measure: Individual metabolomic profile - blood sample
timeFrame: 4 years
measure: Individual genomic profile - saliva sample
timeFrame: 4 years
measure: Short-form-36 (SF-36) questionnaire
timeFrame: 4 years
measure: Routine vital signs - Heart Rate
timeFrame: 4 years
measure: Routine vital signs - Blood Pressure
timeFrame: 4 years
measure: Routine vital signs - Body temperature
timeFrame: 4 years
measure: Neck circumference
timeFrame: 4 years
measure: Waist circumference
timeFrame: 4 years
measure: Bioelectrical impedance analysis (BIA)
timeFrame: 4 years
measure: Food Frequency Questionnaire
timeFrame: 4 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Anna Nolan, MD
role: PRINCIPAL_INVESTIGATOR
References: