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.
Brief Title
Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
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.
Completion Date
Completion Date Type
Actual
Conditions
Lung Injury
Particulate Matter Inhalation Injury
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
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
Inclusion 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
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
Gender
Male
Gender Based
false
Keywords
World Trade Center
Firefighters
FDNY
9/11
Metabolomics
FIREHOUSE
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
90 Years
Minimum Age
21 Years
NCT Id
NCT03581006
Org Class
Other
Org Full Name
NYU Langone Health
Org Study Id
17-00127
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
Primary Outcomes
Outcome Description
Body mass (weight in kg) divided by square of the body height (measured in meters), expressed in units kg/m\^2
Outcome Measure
Body mass index (BMI)
Outcome Time Frame
4 Years
Secondary Outcomes
Outcome Description
Forced expiratory volume (FEV) using spirometer that measures the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
Outcome Time Frame
4 Years
Outcome Measure
Pulmonary Function using FEV Measure
Outcome Description
Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.
Outcome Time Frame
4 Years
Outcome Measure
St. George's Respiratory Questionnaire (SGRQ)
Outcome Description
Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest
Outcome Time Frame
4 years
Outcome Measure
Electrocardiogram (EKG)
Outcome Description
Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.
Outcome Time Frame
4 years
Outcome Measure
Fraction of exhaled nitrous oxide (FENO)
Outcome Description
Non-invasive measurement to ascertain vascular stiffness, by measuring the velocity at which the blood pressure pulse propogates through the circulatory system. This is done using a simple non-invasive blood pressure cuff assessment at the carotid and femoral arteries. It is measured as a velocity, in meters/per second.
Outcome Time Frame
4 years
Outcome Measure
Pulse Wave Velocity (PWV)
Outcome Description
Simple home collection of a stool sample using a sterile collection kit, provided to the human subject. Stool will be used to generate a microbiome profile unique to that individual, reported as bacterial species found in the gut flora, that may predict lung injury. There is no risk to the human subject aside that of providing a stool sample. All individual information is de-identified for personal protection.
Outcome Time Frame
4 years
Outcome Measure
Individual microbiome profile - stool sample
Outcome Description
Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.
Outcome Time Frame
4 years
Outcome Measure
6-minute walk test (6MWT)
Outcome Description
Routine blood testing via sterile phlebotomy to assess metabolic biomarkers that may or may not predict lung injury. These metabolites are generated in all individuals based on their dietary and exercise habits, underlying comorbidities, and unique metabolism. Measured in routine blood samples, and quantified based on unique chemical composition of that molecule. There is no additional risk to the human subject aside that of venipuncture.
Outcome Time Frame
4 years
Outcome Measure
Individual metabolomic profile - blood sample
Outcome Description
Simple home collection of sputum/saliva sample using a buccal swab kit, provided to the human subject. Saliva will be used to generate a genetic profile unique to that individual, reported as chromosomes, genes, and proteins that may predict lung injury. There is no risk to the human subject aside that of providing a sputum sample. All individual information is de-identified for personal protection.
Outcome Time Frame
4 years
Outcome Measure
Individual genomic profile - saliva sample
Outcome Description
Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life
Outcome Time Frame
4 years
Outcome Measure
Short-form-36 (SF-36) questionnaire
Outcome Description
Brief assessment of heart rate (pulse) measured in beats/per minute
Outcome Time Frame
4 years
Outcome Measure
Routine vital signs - Heart Rate
Outcome Description
Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.
Outcome Time Frame
4 years
Outcome Measure
Routine vital signs - Blood Pressure
Outcome Description
Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit
Outcome Time Frame
4 years
Outcome Measure
Routine vital signs - Body temperature
Outcome Description
Assessment of neck circumference using basic measuring tape, recorded in centimeters
Outcome Time Frame
4 years
Outcome Measure
Neck circumference
Outcome Description
Assessment of waist circumference using basic measuring tape, recorded in centimeters
Outcome Time Frame
4 years
Outcome Measure
Waist circumference
Outcome Description
Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.
Outcome Time Frame
4 years
Outcome Measure
Bioelectrical impedance analysis (BIA)
Outcome Description
Paper assessment of typical dietary intake over previous one month, multiple choice answers
Outcome Time Frame
4 years
Outcome Measure
Food Frequency Questionnaire
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry criteria.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
90
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Prezant
Investigator Email
dprezant@montefiore.org
Investigator Phone
dprezant