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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 19, 2019
First Posted Date  ICMJE November 21, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE November 26, 2019
Estimated Primary Completion Date November 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • Adverse Events and Serious Adverse Events [ Time Frame: 4 weeks ]
    Incidence of Adverse Events and Serious Adverse Events
  • Laboratory values [ Time Frame: 4 weeks ]
    Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04172792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2019)
  • 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
  • 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
  • Taste of Intervention [ Time Frame: 2 weeks; 4 weeks ]
    taste of intervention (visual analogous scale); values 1-9, higher values mean better taste
  • Body Weight [ Time Frame: 2 weeks; 4 weeks ]
    change of body weight compared to baseline
  • Biomarkers [ Time Frame: 4 weeks ]
    change of neurofilament light chains (NfL) in serum
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • Appetite [ Time Frame: 2 weeks; 4 weeks ]
    Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline
  • Eating Habits [ Time Frame: 2 weeks; 4 weeks ]
    Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire)
  • Taste of Intervention [ Time Frame: 2 weeks; 4 weeks ]
    taste of intervention (visual analogous scale)
  • Body Weight [ Time Frame: 2 weeks; 4 weeks ]
    change of body weight compared to baseline
  • Biomarkers [ Time Frame: 4 weeks ]
    change of biomarkers of neurodegeneration in blood serum (neurofilaments)
  • 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)
  • ALSFRS-R [ Time Frame: 4 weeks ]
    change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Dietary Supplement: high-caloric fatty diet
    see arm/group description
  • Dietary Supplement: ultra-high-caloric fatty diet
    see arm/group description
  • Dietary Supplement: ultra-high-caloric carbohydrate-rich diet
    see arm/group description
Study Arms  ICMJE
  • Active Comparator: high-caloric fatty diet
    intake of 405 kcal (45g fat) per day in addition to normal food intake
    Intervention: Dietary Supplement: high-caloric fatty diet
  • Experimental: ultra-high-caloric fatty diet
    intake of 810 kcal (90g fat) per day in addition to normal food intake
    Intervention: Dietary Supplement: ultra-high-caloric fatty diet
  • 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
    Intervention: Dietary Supplement: ultra-high-caloric carbohydrate-rich diet
  • No Intervention: control
    normal food intake (no intervention)
Publications * Ludolph A, Drory V, Hardiman O, Nakano I, Ravits J, Robberecht W, Shefner J; WFN Research Group On ALS/MND. A revision of the El Escorial criteria - 2015. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(5-6):291-2. doi: 10.3109/21678421.2015.1049183. Epub 2015 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 25, 2020
Estimated Primary Completion Date November 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04172792
Other Study ID Numbers  ICMJE TOLCAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Albert Christian Ludolph, Prof., University of Ulm
Study Sponsor  ICMJE Albert Christian Ludolph, Prof.
Collaborators  ICMJE Nutritia GmbH, 91052 Erlangen, Germany
Investigators  ICMJE
Principal Investigator: Johannes Dorst, PD Dr. University of Ulm
PRS Account University of Ulm
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP