Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study

Abstract

ObjectiveThere is growing evidence that the course of amyotrophic lateral sclerosis (ALS) may be influenced beneficially by applying high-caloric food supplements (HCSs). However, it is unknown which composition of nutrients offers optimal tolerability and weight gain.MethodsWe conducted a randomised controlled study (Safety and Tolerability of Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS); TOLCAL-ALS study) in 64 patients with possible, probable or definite ALS according to El Escorial criteria. Patients were randomised into four groups: a high-caloric fatty supplement (HCFS; 405 kcal/day, 100% fat), an ultra-high-caloric fatty supplement (UHCFS; 810 kcal/day, 100% fat), an ultra-high-caloric, carbohydrate-rich supplement (UHCCS; 900 kcal/day, 49% carbohydrates) and an open control (OC) group without any supplement. The primary endpoint was tolerability. Patients were followed up over 4 weeks.ResultsGastrointestinal side effects were most frequent in the UHCFS group (75.0%), while loss of appetite was most frequent in the UHCCS group (35.3%). During intervention, patients gained +0.9 kg/month of body weight (IQR −0.9 to 1.5; p=0.03) in the HCFS group and +0.9 kg/month (IQR −0.8 to 2.0; p=0.05) in the UHCFS group. A non-significant trend for weight gain (+0.6 kg/month (IQR −0.3 to 1.9; p=0.08)) was observed in the UHCCS group. Patients in OC group continued to lose body weight (−0.5 kg/month, IQR −1.4 to 1.3; p=0.42).InterpretationThe findings suggest that HCSs frequently cause mild to moderate tolerability issues in patients with ALS, most notably gastrointestinal symptoms in high-fat supplements, and loss of appetite in high-carbohydrate supplements. All three HCSs tested are suited to increase body weight.

Appetite and quality of life in amyotrophic lateral sclerosis: A scoping review

“…The median sample size in the included studies was 56, ranging from 7 to 94. The prevalence of appetite loss in this population, when reported, varied from 18.0% to 53.2% 3,5,9,20,21,25 …”

“…After full‐text review, five articles were excluded (Figure 1). The remaining ten articles met the inclusion criteria and were eligible for data synthesis 3,5,9,19–25 . The earliest publication date was 2010, 19 with most articles (n = 7, 70%) published in 2019 or more recently (Table 1).…”

“…Appetite was assessed in all included studies of which half used the Council of Nutrition Appetite Questionnaire (CNAQ) (n = 5) 3,5,9,21,25 . Six studies reported a mean appetite score 3,9,19,21,24,25 and five studies had specific criteria for changes in appetite 3,5,9,20,21 .…”

“…Table 1 summarizes the general study characteristics of the included articles. 3,5,9,[19][20][21][22][23][24][25] Various study designs were used, including crosssectional studies, case-control studies, randomized controlled trials, and qualitative investigations. The median sample size in the included studies was 56, ranging from 7 to 94.…”

Clinical studies in amyotrophic lateral sclerosis

“…Furthermore, it is unclear whether the potential beneficial effects were mainly driven by the high-energy or the high-fat aspect of the intervention, and what the optimal composition of a high-caloric intervention should look like. A recent open-label study in 64 patients over 4 weeks [39] found that a short-term increase of body weight could be achieved by high-fat as well as high-carbohydrate, high-caloric supplements, although the effect was more pronounced in the high-fat groups. It also indicated that high dosages of high-caloric supplements frequently caused gastrointestinal tolerability issues.…”