Amyotrophic Lateral Sclerosis (ALS)PEGASUSNCT06877143
Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis
A study testing 100% of individual calory requirement and 120% of individual calory requirement in people with Amyotrophic Lateral Sclerosis (ALS), run by University of Ulm at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- 100% of individual calory requirement and 120% of individual calory requirement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Ulm Universita, Department of Neurology
Ulm, Baden-Wurttemberg, 89081
Christine Herrmann, Dr., 0049 731 177 5374, christine.herrmann@uni-ulm.de
Christine Herrmann, Dr.
About this study
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.
Read the detailed description
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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- 100% of individual calory requirement, 120% of individual calory requirement
- Keywords
- ALS, PEG, hypercaloric nutrition, energy deficit
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% of individual calory requirementDietary supplement
Patients receive any PEG nutrition containing the calory requirement as determined by indirect calorimetry, physical activity score and the randomized group.
120% of individual calory requirementDietary supplement
Patients receive any PEG nutrition containing the calory requirement as determined by indirect calorimetry, physical activity score and the randomized group.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Isocaloric nutrition via PEG | Other | Isocaloric nutrition (100% of individual calory requirement as determined by indirect calorimetry and physical activity questionnaire) applied via PEG Receives: Dietary Supplement: 100% of individual calory requirement |
| Group B: Hypercaloric nutrition via PEG | Experimental | Hypercaloric nutrition (120% of individual calory requirement as determined by indirect calorimetry and physical activity questionnaire) applied via PEG Receives: Dietary Supplement: 120% of individual calory requirement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (22)
Survival
time to death or tracheostomy
Measured: 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)
Measured: 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
Measured: 6 months
Slow vital capacity
Slow vital capacity (sVC)
Measured: 6 months
Resting energy expenditure (REE)
Resting Energy Expenditure (REE), measured by indirect calorimetry
Measured: 6 months
Individual Quality of Life
Individual Quality of Life, measured by the Euro Quality of Life (EQ-5D-5L) questionnaire
Measured: 6 months
Appetite
Appetite, measured by the Council of Appetite Questionnaire (CNAQ)
Measured: 6 months
Eating habits
Eating Habits, evaluated by the Ulm Nutrition Questionnaire (UNQ; see LIPCAL study)
Measured: 6 months
Adverse Events
Terms and frequencies of adverse eves (AEs) and serious adverse events (SAEs)
Measured: 6 months
Fatt mass
Fat mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Total Body Water
total body water (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Muscle Mass
muscle mass (% of total body mass) measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Fat Free Mass
fat free mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Body Cell Mass
body cell mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Extracellular Mass
extracellular mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Lean Body Mass
lean body mass (% of total body mass), measured by bioelectrical impedance analysis (BIA)
Measured: 6 months
Beta Hydroxybutyrate
Beta Hydroxybutyrate serum levels
Measured: 6 months
Acetoacetate
Acetoacetate serum levels
Measured: 6 months
Acetone
Acetone concentration in urine
Measured: 6 months
Lipid metabolism
Cholesterol serum levels
Measured: 6 months
Lipid metabolism
High-density-lipoprotein (HDL) serum levels
Measured: 6 months
Lipid metabolism
Low-density-lipoprotein (HDL) serum levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled double-blind study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Christian Ludolph, Prof., University of Ulm
- Investigators
- Christine Herrmann, Dr., Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877143
- Sponsor's protocol ID
- 387/23
- Other IDs
- PEGASUS V 1.0
- Acronym
- PEGASUS
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis
- ClinicalTrials.gov ID
- NCT06877143
- Acronym / sponsor ID
- PEGASUS / 387/23
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- ALS, PEG, hypercaloric nutrition, energy deficit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled double-blind study
| Arm | Type | Receives |
|---|---|---|
| Group A: Isocaloric nutrition via PEG | Other | Dietary Supplement: 100% of individual calory requirementIsocaloric nutrition (100% of individual calory requirement as determined by indirect calorimetry and physical activity questionnaire) applied via PEG |
| Group B: Hypercaloric nutrition via PEG | Experimental | Dietary Supplement: 120% of individual calory requirementHypercaloric nutrition (120% of individual calory requirement as determined by indirect calorimetry and physical activity questionnaire) applied via PEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% of individual calory requirementPatients receive any PEG nutrition containing the calory requirement as determined by indirect calorimetry, physical activity score and the randomized group. | Dietary supplement | Group A: Isocaloric nutrition via PEG |
| 120% of individual calory requirementPatients receive any PEG nutrition containing the calory requirement as determined by indirect calorimetry, physical activity score and the randomized group. | Dietary supplement | Group B: Hypercaloric nutrition via PEG |
Primary outcome
Neurofilament light chain (NfL) in serum
Time frame: 6 months
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).
22 secondary outcomes
Survival
Time frame: 6 months
ALS functional rating scale revised (ALSFRS-R)
Time frame: 6 months
Body mass index (BMI)
Time frame: 6 months
Slow vital capacity
Time frame: 6 months
Resting energy expenditure (REE)
Time frame: 6 months
Individual Quality of Life
Time frame: 6 months
Appetite
Time frame: 6 months
Eating habits
Time frame: 6 months
Adverse Events
Time frame: 6 months
Fatt mass
Time frame: 6 months
Total Body Water
Time frame: 6 months
Muscle Mass
Time frame: 6 months
Fat Free Mass
Time frame: 6 months
Body Cell Mass
Time frame: 6 months
Extracellular Mass
Time frame: 6 months
Lean Body Mass
Time frame: 6 months
Beta Hydroxybutyrate
Time frame: 6 months
Acetoacetate
Time frame: 6 months
Acetone
Time frame: 6 months
Lipid metabolism
Time frame: 6 months
Lipid metabolism
Time frame: 6 months
Lipid metabolism
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Desport JC, Preux PM, Truong TC, Vallat JM, Sautereau D, Couratier P. Nutritional status is a prognostic factor for survival in ALS patients. Neurology 1999; 53(5): 1059-63.Link provided by the sponsor.
- Dupuis L, Oudart H, Rene F, Gonzalez de Aguilar JL, Loeffler JP. Evidence for defective energy homeostasis in amyotrophic lateral sclerosis: benefit of a high-energy diet in a transgenic mouse model. Proc Natl Acad Sci U S A 2004; 101(30): 11159-64.Link provided by the sponsor.
- Dupuis L, Pradat PF, Ludolph AC, Loeffler JP. Energy metabolism in amyotrophic lateral sclerosis. Lancet Neurol 2011; 10(1): 75-82.Link provided by the sponsor.
- Fayemendy P, Marin B, Labrunie A, et al. Hypermetabolism is a reality in amyotrophic lateral sclerosis compared to healthy subjects. J Neurol Sci 2021; 420(117257): 3.Link provided by the sponsor.
- Dorst J, Cypionka J, Ludolph AC. High-caloric food supplements in the treatment of amyotrophic lateral sclerosis: A prospective interventional study. Amyotroph Lateral Scler Frontotemporal Degener 2013; 14(7-8): 533-6.Link provided by the sponsor.
- Ludolph AC, Dorst J, Dreyhaupt J, et al. Effect of high-caloric nutrition on survival in amyotrophic lateral sclerosis. Ann Neurol 2019; 17(10): 25661.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Herrmann, Dr. principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% of individual calory requirement and 120% of individual calory requirement in people with Amyotrophic Lateral Sclerosis (ALS), run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Herrmann, Dr. (0049 731 177 5374, christine.herrmann@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofilament light chain (NfL) in serum (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.