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High-caloric interventions, including a high-caloric fatty supplement and a carbohydrate-rich high-caloric supplement, were able to induce weight gain in patients with amyotrophic lateral sclerosis (ALS). However, gastrointestinal (GI) symptoms and loss of appetite were the two common tolerability issues with high-fat and high-carbohydrate supplements, respectively. These findings were published in the Journal of Neurology, Neurosurgery, and Psychiatry.
In ALS, weight loss is an independent prognostic factor and can increase the mortality rate by 30% per 1 point loss of body mass index (BMI). Previous research in both humans and mice with ALS have found high-caloric, carbohydrate-rich nutrition can prolong survival. However, it’s unclear what nutrients provide the best tolerability and weight gain among this patient population.
The researchers conducted a prospective, randomized, parallel-group, controlled study, Safety and Tolerability of Ultra-high-caloric Food Supplements in Amytrophic Lateral Sclerosis (TOLCAL) (ALS), (ClinicalTrials.gov identifier: NCT04172792) to compare various high-caloric food supplements (HCSs) as add-on therapy to normal food intake and standard treatment (ie, riluzole) in patients with ALS.
From November 21, 2019, through February 22,. 2021, 64 patients with ALS, according to El Escorial World Federation of Neurology criteria, were screened in the Department of Neurology, Ulm University, located in Ulm, Baden-Württemberg, Germany. All patients with possible or probable ALS were randomized in a 1:1:1:1 ratio to 1 of 4 arms: (1) a high-caloric fatty supplement (HCFS); 405 kcal/day; 100% fat group (n=15), (2) an ultra-high-caloric, fatty supplement (UHCFS) 810 kcal/day; 100% fat group (n=16), (3) an ultra-high-caloric, carbohydrate-rich supplement (UHCCS); 900 kcal/day; 49% carbohydrates group (n=17), or (4) an open-control group (n=16) who did not receive any supplement. The primary study endpoint was tolerability. All of the participants were followed for 4 weeks.
The findings showed that GI side effects are most common in the UHCFS arm (75.0%), whereas loss of appetite was reported most often in the UHCCS arm (35.5%). During the intervention, participants gained +0.9 kg/month of body weight (range, –0.9 to 1.5 kg/month; P =.03) in the HCFS group compared with +0.9 kg/month (range, –0.8 to 2.0 kg/month; P =.05) in the UHCFS group.
A trend for weight gain that was not statistically significant was observed in the UHCCS arm. Participants in the open-control group continued to lose body weight (–0.5 kg/month; range, –1.4 to 1.3 kg/month; P =.42).
The study had several limitations, including a short intervention period (4 weeks), the reliance on pre-baseline data that used anamnestic information to compare body weight changes during the study, and an imbalance of baseline characteristics between groups, according to the researchers.
“All three HCSs tested are suited to increase body weight,” among patients with ALS, the researchers concluded. The results demonstrate that fat-rich and mixed/carbohydrate-rich HCS are promising candidates for future trials in patients with ALS. Of note, increases in dosages beyond the UHCFS dosage utilized in the present study are not recommended in this patient population.
Disclosure: None of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies.
Reference
Dorst J, Doenz J, Kandler K, et al. Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study. J Neurol Neurosurg Psychiatry. Published online January 12, 2022. doi:10.1136/jnnp-2021-328331
