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Completed

NCT Number: NCT04172792

Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)

The LIPCAL-ALS study (NCT02306590) has provided preliminary evidence that a high-caloric nutrition might prolong survival in fast-progressing ALS patients. Since increasing the amount of calories of the intervention might possibly increase the beneficial effect, the investigators seek to investigate whether an ultra-high caloric diet (UHCD), featuring the double amount of calories compared to LIPCAL-ALS, will be well tolerated by ALS patients and may serve as an intervention for a potential LIPCALII study. For this purpose, the investigators will compare two different UHCDs (one fat-rich and one carbohydrate-rich) with regard to safety and tolerability over a time frame of 4 weeks. A third group will receive the original diet from LIPCAL, and a fourth group will receive no intervention (control group).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Ulm, Department of Neurology

Ulm, Baden-Wurttemberg, 89081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the revised version of the El Escorial criteria (Ludolph et al. 2015)
  • Slope of ALS Functional Rating Scale Revised (ALSFRS-R) of >0.25 points per month at baseline visit based on the formula (48 - score at baseline visit) / (time between date of first symptom and baseline visit)
  • stable on standard therapy riluzole (100 mg/day) for at least 4 weeks
  • capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)

Exclusion criteria

  • already taking any dietary supplements
  • participation in another clinical trial within the preceding 8 weeks
  • tracheostomy or assisted ventilation of any type which exceeds 23 hours per day
  • pregnancy or breast-feeding females

Treatment and study plan

high-caloric fatty diet

Dietary Supplement

see arm/group description

ultra-high-caloric fatty diet

Dietary Supplement

see arm/group description

ultra-high-caloric carbohydrate-rich diet

Dietary Supplement

see arm/group description

Primary outcomes

  1. Adverse Events and Serious Adverse Events

    Time frame: 4 weeks

    Incidence of Adverse Events and Serious Adverse Events

  2. Laboratory values

    Time frame: 4 weeks

    Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations

Secondary outcomes

  1. Appetite

    Time frame: 2 weeks; 4 weeks

    Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite

  2. Eating Habits

    Time frame: 2 weeks; 4 weeks

    Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score

  3. Taste of Intervention

    Time frame: 2 weeks; 4 weeks

    taste of intervention (visual analogous scale); values 1-9, higher values mean better taste

  4. Body Weight

    Time frame: 2 weeks; 4 weeks

    change of body weight compared to baseline

  5. Biomarkers

    Time frame: 4 weeks

    change of neurofilament light chains (NfL) in serum

  6. Adverse Events and Serious Adverse Events

    Time frame: 6 weeks

    Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)

  7. ALSFRS-R

    Time frame: 4 weeks

    change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment

Sponsors and collaborators

Lead sponsor

Albert Christian Ludolph, Prof.

Other

Collaborators

  • Nutritia GmbH, 91052 Erlangen, Germany

Registry information

Official study title

Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)

Acronym: TOLCAL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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