New York University School of Medicine
New York, 10016, United States
NCT Number: NCT03581006
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.
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Notify Me21 year–90 year
Male
Observational
New York, 10016, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 group, who will receive no dietary or behavioral intervention during the trial
Other names: Control group
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
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.
Time frame: 4 Years
Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.
Time frame: 4 years
Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest
Time frame: 4 years
Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.
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.
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.
Time frame: 4 years
Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.
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.
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.
Time frame: 4 years
Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life
Time frame: 4 years
Brief assessment of heart rate (pulse) measured in beats/per minute
Time frame: 4 years
Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.
Time frame: 4 years
Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit
Time frame: 4 years
Assessment of neck circumference using basic measuring tape, recorded in centimeters
Time frame: 4 years
Assessment of waist circumference using basic measuring tape, recorded in centimeters
Time frame: 4 years
Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.
Time frame: 4 years
Paper assessment of typical dietary intake over previous one month, multiple choice answers
NYU Langone Health
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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