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

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ClinicalTrials.gov Identifier: NCT04172792
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Nutritia GmbH, 91052 Erlangen, Germany
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: high-caloric fatty diet Dietary Supplement: ultra-high-caloric fatty diet Dietary Supplement: ultra-high-caloric carbohydrate-rich diet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : November 25, 2020


Arm Intervention/treatment
Active Comparator: high-caloric fatty diet
intake of 405 kcal (45g fat) per day in addition to normal food intake
Dietary Supplement: high-caloric fatty diet
see arm/group description

Experimental: ultra-high-caloric fatty diet
intake of 810 kcal (90g fat) per day in addition to normal food intake
Dietary Supplement: ultra-high-caloric fatty diet
see arm/group description

Experimental: ultra-high-caloric carbohydrate-rich diet
intake of 900 kcal (111.4g carbohydrate, 34.9g fat, 36.0g protein) in addition to normal food intake
Dietary Supplement: ultra-high-caloric carbohydrate-rich diet
see arm/group description

No Intervention: control
normal food intake (no intervention)



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04172792


Contacts
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Contact: Johannes Dorst, PD Dr. +49 731 177 5285 johannes.dorst@uni-ulm.de
Contact: Joachim Schuster, PhD +49 731 500 63000 joachim.schuster@uni-ul.de

Locations
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Germany
University of Ulm, Department of Neurology Recruiting
Ulm, Baden-Wurttemberg, Germany, 89081
Contact: Johannes Dorst, PD Dr.    +49 731 177 5285    johannes.dorst@uni-ulm.de   
Sponsors and Collaborators
Albert Christian Ludolph, Prof.
Nutritia GmbH, 91052 Erlangen, Germany
Investigators
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Principal Investigator: Johannes Dorst, PD Dr. University of Ulm

Publications:
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Responsible Party: Albert Christian Ludolph, Prof., Prof. Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT04172792     History of Changes
Other Study ID Numbers: TOLCAL
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available beginning 3 months and ending 5 years following article publication. Data will be shard with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data acess agreement. The study protocol will be available for 5 years at htpps://www.uniklinik-ulm.de/neurologie.html.
Supporting Materials: Study Protocol
Time Frame: 3 month after publication until 5 years after 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. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data acess agreement.
URL: https://www.uniklinik-ulm.de/neurologie.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases