Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis

Launched by UNIVERSITY OF ULM · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a specific type of high-calorie nutrition, given through a feeding tube (known as PEG), can help people with amyotrophic lateral sclerosis (ALS) maintain their weight and potentially slow down the progression of the disease. Weight loss can be a serious concern for ALS patients, so the trial aims to compare the effects of a hypercaloric diet, which provides 120% of the energy needed, to a regular isocaloric diet, which meets standard energy needs. Researchers believe that the high-calorie diet may lead to better health outcomes over six months.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of ALS. They should also be receiving nutrition through a PEG and have experienced a certain level of decline in their ALS symptoms. Those who are pregnant, breastfeeding, or have certain mental health issues may not be eligible. Participants will receive nutritional support and will have their health monitored closely throughout the study. This trial is currently recruiting and aims to include about 76 patients to better understand the impact of this dietary approach on ALS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria 1
• • Loss of ALS functional rating scale revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis) based on the formula: (48 - Score at Screening Visit) / (Months between Onset and Screening Visit)
• • Nutrition via PEG
• • Age ≥18 years
• • Intake of a stable dose of riluzole for at least 4 weeks, or no riluzole
• • Capable of thoroughly understanding all information given and giving full informed consent according to GCP
• Exclusion Criteria:
• • Previous participation in another interventional study within the preceding 4 weeks
• • Absence of adequate social support and cooperation, or personal motivation (in the judgment of the investigator) to complete the study satisfactorily
• • Pregnancy or breast-feeding females
• • Evidence of a major psychiatric disorder or clinically evident dementia