An interventional study of 100% of individual calory requirement and 120% of individual calory requirement in Amyotrophic Lateral Sclerosis (ALS), sponsored by University of Ulm. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by University of Ulm · Not applicable, Interventional, and Treatment
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 indirect calorimetry and activity questionnaire. The investigators hypothsize, that a hypercaloric PEG nutrition slows down disease progression as measured by neurofilament light chains (NfL) in serum after 6 months compared to placebo. Power calculation relies on the results of the lipids and calories for ALS (LIPCAL-ALS) study which tested the effect of an oral high-caloric fatty nutritional supplement in ALS. The study revealed that NfL serum values declined significantly in the intervention group while remaining stable in the placebo group over the course of the study. Assuming a similar effect size, we calculated that 76 patients had to be included in the current trial.
Patients eligible for study participation will be randomized to one of two groups (hypercaloric or isocaloric diet) at baseline visit. Intervention or control diet will be administered as an add-on to standard therapy. Calory requirement will be individually determined by indirect calorimetry which measures resting energy expenditure (REE) and by collecting physical activity data. Indirect calorimetry is a non-invasive procedure which allows to calculate resting energy expenditure by measuring carbon dioxide and oxygen in the expired air using a canopy hood or a full-face mask. For both groups, a standard PEG nutrition featuring a balanced ratio of fat, carbohydrates, and protein according to human requirements will be used (e.g. Fresenius Fresubin® Energy Fibre/2250 Complete).
PEG nutrition used in this study (e.g. Fresenius Fresubin® Energy Fibre/2250 Complete) is routinely used in clinical practice for feeding of patients with ALS and PEG. It is known to be well tolerable and safe. In few cases of intolerance, this standard tube feeding may be switched to another product (e. g. HiPP Sondennahrung), but the amount of calories will not be changed.
In clinical routine, energy needs are usually estimated using the Harris-Benedict-formula, based on body weight, height, sex and age. However, this formula only provides approximate values. Therefore, in this study, indirect calorimetry is used to obtain precise values of energy needs. The German version of the International Physical Activity Questionnaire Short Last 7 Days Self-administered Format (IPAQ) is used for determining the physical activity level. The total energy requirement is calculated by adding the resting energy expenditure and the activity-related calorie requirement.
In the control group, 100% of the estimated calorie requirement is administered with the goal of covering energy needs and stabilizing body weight. The hypercaloric diet in the intervention group consists in 120% of the calorie requirement determined by indirect calorimetry. Resting energy expenditure in ALS patients is 14% higher than in a healthy control cohort. We assume that activity-related energy expenditure is increased similarly. Therefore, the hypercaloric diet consisting in 120% of calorie requirement aims to cover these additional energy needs. Similarly, a recent study in patients with PEG used 125% of calorie requirement.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's planned enrollment of 76 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Isocaloric nutrition (100% of individual calory requirement as determined by indirect calorimetry and physical activity questionnaire) applied via PEG
Dietary Supplement: 100% of individual calory requirement
Hypercaloric nutrition (120% of individual calory requirement as determined by indirect calorimetry and physical activity questionnaire) applied via PEG
Dietary Supplement: 120% of individual calory requirement
Patients receive any PEG nutrition containing the calory requirement as determined by indirect calorimetry, physical activity score and the randomized group.
Patients receive any PEG nutrition containing the calory requirement as determined by indirect calorimetry, physical activity score and the randomized group.
Neurofilament light chain (NfL) in serum
Change of neurofilament light chain (NfL) concentration in serum after 6 months compared to baseline. The change will be measured as individual NfL slope from baseline to 6 months (change per month).
Time frame: 6 months
Survival
time to death or tracheostomy
Time frame: 6 months
ALS functional rating scale revised (ALSFRS-R)
Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score, measured as individual slope (loss of points per month)
Time frame: 6 months
Body mass index (BMI)
Body Mass Index (BMI), weight (in kg) and height (in m) will be combined to report BMI in kg/m\^2
Time frame: 6 months
Slow vital capacity
Slow vital capacity (sVC)
Time frame: 6 months
Resting energy expenditure (REE)
Resting Energy Expenditure (REE), measured by indirect calorimetry
Time frame: 6 months
Individual Quality of Life
Individual Quality of Life, measured by the Euro Quality of Life (EQ-5D-5L) questionnaire
Time frame: 6 months
Appetite
Appetite, measured by the Council of Appetite Questionnaire (CNAQ)
Time frame: 6 months
Eating habits
Eating Habits, evaluated by the Ulm Nutrition Questionnaire (UNQ; see LIPCAL study)
Time frame: 6 months
Adverse Events
Terms and frequencies of adverse eves (AEs) and serious adverse events (SAEs)
Time frame: 6 months
Fatt mass
Fat mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Total Body Water
total body water (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Muscle Mass
muscle mass (% of total body mass) measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Fat Free Mass
fat free mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Body Cell Mass
body cell mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Extracellular Mass
extracellular mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Lean Body Mass
lean body mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Time frame: 6 months
Beta Hydroxybutyrate
Beta Hydroxybutyrate serum levels
Time frame: 6 months
Acetoacetate
Acetoacetate serum levels
Time frame: 6 months
Acetone
Acetone concentration in urine
Time frame: 6 months
Lipid metabolism
Cholesterol serum levels
Time frame: 6 months
Lipid metabolism
High-density-lipoprotein (HDL) serum levels
Time frame: 6 months
Lipid metabolism
Low-density-lipoprotein (HDL) serum levels
Time frame: 6 months
Plan to share: Yes — Individual participant data after de-identification as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims provided in the approved proposal. Proposals should be directed to christine.herrmann@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement.
Supporting information: Study protocol
Time frame: 3 months to 5 years following article publication
Access criteria: Data will be shard for analyses to achieve the aims provided in the approved proposal. Proposals should be directed to christine.herrmann@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement.
Data sharing details ↗ · www.uniklinik-ulm.de
Started Mar 2025 (actual). Primary completion is estimated for Mar 2031, 72 months after the start.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 72 months is above that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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