Ultra-high-caloric, Fatty Diet in ALS

NCT06280079 | Recruiting

• 1 other identifier: LIPCAL-ALS II 1.1
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 23

Brief Summary

This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; High-caloric, high-fat nutrition; Survival; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Survival

  Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (\>22 hours per day)

  18 months

Secondary Outcomes (16)

• Amyotrophic Lateral Sclerosis Functional Rating Scale Revised

  18 months

• Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale

  18 months

• Individual Quality of Life

  18 months

• Slow vital capacity

  18 months

• Survival

  6 months

Other Outcomes (36)

• Microtubule-associated protein 2 in serum

  18 months

• Microtubule-associated protein 2 in cerebrospinal fluid

  18 months

• Ubiquitin carboxy-terminal hydrolase L1 in serum

  18 months

Study Arms (2)

Ultra-high-caloric fatty diet

EXPERIMENTAL

ultra-high-caloric, high-fat, fluid nutritional supplement oral intake of 4 times 35 ml per day in addition to normal food intake, corresponding to +630 kcal and +70g fat per day

Dietary Supplement: Ultra-high-caloric fatty diet

Placebo

PLACEBO COMPARATOR

placebo, fluid nutritional supplement oral intake of 4 times 35 ml per day in addition to normal food intake, corresponding to +50 kcal and +3,5g fat per day

Other: Placebo

Interventions

Ultra-high-caloric fatty diet DIETARY_SUPPLEMENT

100% fat (70g), saturated fatty acids 7,5g, monounsaturated fatty acids 42,6g, polyunsaturated fatty acids 19,9g, long-chain fatty acids 100%, ratio omega-6 to omega-3 fatty acids 5:1, protein 0g, carbohydrates 0g, fiber 0g

Ultra-high-caloric fatty diet

Placebo OTHER

\<5% fat (\<3,5g), protein 0g, carbohydrates 0g, fiber 0g

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Capable of thoroughly understanding all information given
• full written informed consent according to good clinical practice

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (23)

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

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Johannes Dorst, Prof. Dr.

  University of Ulm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Dorst, Prof. Dr.

CONTACT

+497311775285; johannes.dorst@uni-ulm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.

Locations

DE (23)