(HealthDay News) — In patients with amyotrophic lateral sclerosis (ALS), a high-calorie, enteral diet is safe and tolerable and improves survival, according to a small study published online February 28 in The Lancet.
Previous studies have suggested that mild obesity and high-calorie diets are associated with improved survival in ALS. Anne-Marie Wills, MD, from Massachusetts General Hospital in Boston, and colleagues conducted a double-blind, placebo-controlled, randomized phase 2 clinical trial of 24 patients with ALS to assess the safety and tolerability of two hypercaloric diets. Patients were randomly assigned to either a control diet of replacement calories using an isocaloric tube-fed diet, a high-carbohydrate hypercaloric (HC/HC) tube-fed diet, or a high-fat hypercaloric tube-fed diet for four months.
According to the researchers, during five months of follow-up, patients in the high-carbohydrate diet group had fewer total adverse events compared with the control and high-fat diet groups (23 vs. 42 and 48, respectively; overall, P=0.06; HC/HC versus control, P=0.06) and significantly fewer serious adverse events than those on the control diet (zero vs. nine; P=0.0005). The high-carbohydrate group also had fewer study discontinuations than the control group (0 versus 50%) and fewer deaths than the control group (0 vs. 43%). Adverse events, tolerability, deaths, and disease progression did not differ significantly between any of the groups.
“Our results provide preliminary evidence that hypercaloric enteral nutrition is safe and tolerable in patients with ALS, and support the study of nutritional interventions in larger randomized controlled trials at earlier stages of the disease,” Wills and colleagues conclude.
Several authors disclosed financial ties to the pharmaceutical industry.