NCT03581006

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Male
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Injury
• Particulate Matter Inhalation Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-12
• Primary completion: 2021-03-04
• Completion: 2021-03-04
• First posted: 2018-07-10
• Last updated: 2021-12-03

Locations

1 site across 1 country: United States