Condition: Amyotrophic Lateral Sclerosis (ALS) · Sponsor: University of Ulm
Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). Over the last years, various interventional studies targeting the energy deficit in ALS yielded promising results; however,it is still unclear which kind of nutrition or nutritional supplement is most beneficial. Moreover, there is lack of evidence regarding interventions in patients with a PEG in later disease stages.In a pilot study conducted in 2013, it was demonstrated that body weight can be stabilized in ALS by applying either a fat-rich or carbohydrate-rich high-caloric food supplement. In 2014, Wills et al. conducted a placebo-controlled randomized controlled pilot study, which indicated that a carbohydrate-rich, hypercaloric diet, consisting in 125% of estimated energy requirements as determined by indirect calorimetry, in patients fed via percutaneous endoscopic gastrostomy was safe and well tolerated. Moreover, these patients showed longer survival than patients fed with a fat-rich, hypercaloric diet or an isocaloric diet . Hypercaloric, high-carbohydrate diet also showed beneficial effects on body weight and Body Mass Index . Although these results were promising, the low number of patients (n=24) was a severe limiting factor of this study. The aim of this study is to investigate the effect of a hypercaloric PEG nutrition, consisting of 120% of estimated calorie requierements, compared to an isocaloric nutrition. Individual energy requirement is determined by performing indir…
This description comes directly from the study's public registry record.
Christine Herrmann, Dr. · 0049 731 177 5374 · christine.herrmann@uni-ulm.de
Johannes Dorst, Prof. Dr. · 0049 731 177 5285 · johannes.dorst@uni-ulm.de
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| Ulm Universita, Department of Neurology | Ulm, Baden-Wurttemberg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06877143