Specialist Dietary Intervention in Patients With Fibrotic Interstitial Lung Disease Experiencing Unintentional Weight Loss: A Pilot Randomized Controlled Trial.

Abstract

Weight loss in patients with fibrotic interstitial lung disease (F-ILD) is associated with poor prognosis, yet the impact of dietary input is unknown. What is the feasibility of a randomized controlled trial of specialist dietary intervention in F-ILD? Patients with F-ILD experiencing low weight or weight loss were randomized 1:1 to either a 12-week specialist dietary intervention or a dietary information sheet by computer-generated sequence using random block design with stratification by antifibrotic drugs. The primary outcome was feasibility of recruitment, randomization, and retention. A key predefined exploratory outcome was weight change from baseline. Of 128 screened patients, 40 patients (31%) were randomized, 19 to diet and 21 to control arm. The target number of patients was reached within 7 months, suggesting feasibility of a larger trial. All randomized patients completed the study. In the diet arm, 8 of 19 (42%) vs 1 of 21 (4.8%) participants in the control arm gained ≥ 1 kg at 12 weeks (OR, 14.2; 95% CI, 1.4-141.8; P = .02). Analysis of the exploratory outcome of weight change revealed that after a 4-week lag, the estimated rate of weight change between 4 and 12 weeks was -0.25 kg/month (95% CI, -0.61 to 0.12) in the control and +0.40 kg/month (95% CI, 0.02 to 0.78) in the diet group, with a difference of +0.65 kg/month (95% CI, 0.15 to 1.14) in favor of the diet group (P = .01). Based on the encouraging results of this pilot trial of dietary intervention in F-ILD, a definitive multicenter randomized controlled trial is warranted. ClinicalTrials.gov; No.: NCT06016959; URL: www. gov).