High-caloric fatty diet for patients with ALS
Efficacy, Safety, and Tolerability of Ultra-high-caloric, Fatty Diet (UFD) in Amyotrophic Lateral Sclerosis (ALS)
This study is testing if a high-calorie, fatty diet can help people with ALS live longer and maintain their weight better than a regular diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 392 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm Academic / other |
| Locations | 23 sites (Aachen and 22 other locations) |
| Trial ID | NCT06280079 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and tolerability of an ultra-high-caloric, fatty diet compared to a placebo in patients diagnosed with amyotrophic lateral sclerosis (ALS). ALS is a severe neurodegenerative condition that leads to muscle paralysis and ultimately respiratory failure. The study aims to improve survival rates by addressing the unique metabolic challenges faced by ALS patients, particularly their increased resting energy expenditure and weight loss. Previous research has indicated that high-caloric diets may prolong survival and reduce weight loss in ALS patients, prompting this investigation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of ALS and a disease duration of less than 24 months.
Not a fit: Patients with advanced ALS or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance survival and quality of life for ALS patients by addressing their nutritional needs.
How similar studies have performed: While previous studies have shown mixed results, some have indicated potential benefits of high-caloric diets in ALS, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria * Disease duration (onset of first paresis or bulbar symptoms) \< 24 months * Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit) * Age ≥18 years. * Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion * Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion * Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion * Capable of thoroughly understanding all information given * full written informed consent according to good clinical practice Exclusion Criteria: * Previous participation in another interventional study involving an active treatment within the preceding 4 weeks * Tracheostomy or continuous permanent ventilator dependence (\>22 hours per day) * Pregnancy or breastfeeding * Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS * Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. * Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. * Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency
Where this trial is running
Aachen and 22 other locations
- RWTH Aachen — Aachen, Germany (Not_yet_recruiting)
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- University Clinic Bochum — Bochum, Germany (Not_yet_recruiting)
- University Clinic Bonn — Bonn, Germany (Not_yet_recruiting)
- Technical University Dresden — Dresden, Germany (Not_yet_recruiting)
- University Clinic Erlangen — Erlangen, Germany (Not_yet_recruiting)
- Alfried Krupp Krankenhaus Essen — Essen, Germany (Not_yet_recruiting)
- University Clinic Göttingen — Göttingen, Germany (Not_yet_recruiting)
- University Clinic Halle — Halle, Germany (Not_yet_recruiting)
- Hannover Medical School — Hanover, Germany (Not_yet_recruiting)
- University Clinic Jena — Jena, Germany (Not_yet_recruiting)
- DRK Clinic Kassel — Kassel, Germany (Not_yet_recruiting)
- Klinikum Kempten — Kempten, Germany (Not_yet_recruiting)
- University Clinic Leipzig — Leipzig, Germany (Not_yet_recruiting)
- University Clinic Lübeck — Lübeck, Germany (Recruiting)
- Diakonissenkrankenhaus Mannheim — Mannheim, Germany (Recruiting)
- Technical University Munich — Munich, Germany (Not_yet_recruiting)
- University Clinic Münster — Münster, Germany (Not_yet_recruiting)
- University Clinic Regensburg — Regensburg, Germany (Not_yet_recruiting)
- University Clinic Rostock — Rostock, Germany (Not_yet_recruiting)
- University of Ulm — Ulm, Germany (Recruiting)
- DKD HELIOS Clinic Wiesbaden — Wiesbaden, Germany (Recruiting)
- University Clinic Würzburg — Würzburg, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Johannes Dorst, Prof. Dr. — University of Ulm
- Study coordinator: Johannes Dorst, Prof. Dr.
- Email: johannes.dorst@uni-ulm.de
- Phone: +497311775285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.