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

Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581006
• Other study ID #: 17-00127
• Status: Completed
• Start date: November 12, 2018
• Est. completion date: March 4, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Particulate Matter Inhalation Injury
• Wounds and Injuries

Intervention

Dietary Supplement:
• 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

Combination Product:
• Technology based monitoring and behavioral participation
Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI)	Body mass (weight in kg) divided by square of the body height (measured in meters), expressed in units kg/m^2	4 Years
Secondary	Pulmonary Function using FEV Measure	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
Secondary	St. George's Respiratory Questionnaire (SGRQ)	Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.	4 Years
Secondary	Electrocardiogram (EKG)	Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest	4 years
Secondary	Fraction of exhaled nitrous oxide (FENO)	Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.	4 years
Secondary	Pulse Wave Velocity (PWV)	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
Secondary	Individual microbiome profile - stool sample	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
Secondary	6-minute walk test (6MWT)	Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.	4 years
Secondary	Individual metabolomic profile - blood sample	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
Secondary	Individual genomic profile - saliva sample	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
Secondary	Short-form-36 (SF-36) questionnaire	Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life	4 years
Secondary	Routine vital signs - Heart Rate	Brief assessment of heart rate (pulse) measured in beats/per minute	4 years
Secondary	Routine vital signs - Blood Pressure	Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.	4 years
Secondary	Routine vital signs - Body temperature	Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit	4 years
Secondary	Neck circumference	Assessment of neck circumference using basic measuring tape, recorded in centimeters	4 years
Secondary	Waist circumference	Assessment of waist circumference using basic measuring tape, recorded in centimeters	4 years
Secondary	Bioelectrical impedance analysis (BIA)	Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.	4 years
Secondary	Food Frequency Questionnaire	Paper assessment of typical dietary intake over previous one month, multiple choice answers	4 years