Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial

December 1, 2021 updated by: NYU Langone Health
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention Group

This observational cohort study will follow firefighters enrolled in Monitoring and Treatment Program. Investigators will include firefighters in the validation cohort who were present at the WTC site within 3 days of 9/11, have consent, and have abnormal post-9/11 lung function.

This intervention group will undergo technology based monitoring and behavioral participation in a dietary and exercise program with the intent of weight loss and compliance with a low-calorie Mediterranean diet.

Participants in the intervention group will receive 6 months of education and behavioral counseling with self-monitoring to help them adopt a Mediterranean-style, calorie-restricted diet, and engage in physical activity
Other Names:
  • LoCalMed
Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary
Other Names:
  • LoCalMed
Control (Usual care) Group

This observational cohort study will follow firefighters enrolled in Monitoring and Treatment Program. Investigators will include firefighters in the validation cohort who were present at the WTC site within 3 days of 9/11, have consent, and have abnormal post-9/11 lung function.

This group will receive no dietary or behavioral intervention. They will continue usual care with their home physicians.

Control group, who will receive no dietary or behavioral intervention during the trial
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: 4 Years
Body mass (weight in kg) divided by square of the body height (measured in meters), expressed in units kg/m^2
4 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function using FEV Measure
Time Frame: 4 Years
Forced expiratory volume (FEV) using spirometer that measures the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
4 Years
St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 4 Years
Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.
4 Years
Electrocardiogram (EKG)
Time Frame: 4 years
Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest
4 years
Fraction of exhaled nitrous oxide (FENO)
Time Frame: 4 years
Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.
4 years
Pulse Wave Velocity (PWV)
Time Frame: 4 years
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.
4 years
Individual microbiome profile - stool sample
Time Frame: 4 years
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.
4 years
6-minute walk test (6MWT)
Time Frame: 4 years
Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.
4 years
Individual metabolomic profile - blood sample
Time Frame: 4 years
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.
4 years
Individual genomic profile - saliva sample
Time Frame: 4 years
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.
4 years
Short-form-36 (SF-36) questionnaire
Time Frame: 4 years
Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life
4 years
Routine vital signs - Heart Rate
Time Frame: 4 years
Brief assessment of heart rate (pulse) measured in beats/per minute
4 years
Routine vital signs - Blood Pressure
Time Frame: 4 years
Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.
4 years
Routine vital signs - Body temperature
Time Frame: 4 years
Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit
4 years
Neck circumference
Time Frame: 4 years
Assessment of neck circumference using basic measuring tape, recorded in centimeters
4 years
Waist circumference
Time Frame: 4 years
Assessment of waist circumference using basic measuring tape, recorded in centimeters
4 years
Bioelectrical impedance analysis (BIA)
Time Frame: 4 years
Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.
4 years
Food Frequency Questionnaire
Time Frame: 4 years
Paper assessment of typical dietary intake over previous one month, multiple choice answers
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anna Nolan, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2018

Primary Completion (Actual)

March 4, 2021

Study Completion (Actual)

March 4, 2021

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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