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Trial record 2 of 8 for:    calorie als

Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306590
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Brief Summary:

The primary objective of the trial is to investigate the survival time (the time from randomization until death or date of end of the study) compared between control group and experimental group.

This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 200 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: Calogen Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : February 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: Study Intervention
High caloric fatty diet for drinking (100% lipids, 4.5 kcal/ml) 405 kcal/90 ml/day in addition to daily food intake and standard of care; corresponding to an additional intake of 45 g fat per day
Dietary Supplement: Calogen
Placebo Comparator: Placebo
Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Survival in ALS-patients with study intervention compared to placebo [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Change of total ALS functional rating scale revised (ALSFRS-R) [ Time Frame: 18 months ]
  2. Change of individual quality of life (SEIQoL) [ Time Frame: 18 months ]
  3. Change of the slow vital capacity (sVC) [ Time Frame: 18 months ]
  4. Time to tracheostomy or death (combined) [ Time Frame: 18 months ]
  5. Change of Body Mass Index (BMI) [ Time Frame: 18 months ]
  6. Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) [ Time Frame: 18 months ]


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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:

  • Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
  • Disease duration < 36 months
  • Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
  • Age ≥18 years
  • Continuously treated with 100 mg riluzole daily for at least four weeks
  • Capable of thoroughly understanding all information given and giving full informed consent according to GCP
  • Willing to complete a diet questionnaire throughout participation in the study

Exclusion Criteria:

  • Simultaneous participation in another interventional clinical study
  • Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
  • Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
  • Tracheostomy
  • Patients with gastrostomy
  • 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.

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): NCT02306590


Locations
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Germany
Department of Neurology, University of Ulm
Ulm, Baden-Württemberg, Germany, 89081
Department of Neurology, University of Wuerzburg
Wuerzburg, Bayern, Germany, 91054
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany, D-18147
Department of Neurology, Medical School Hannover
Hannover, Niedersachsen, Germany, 30625
Department of Neurology, University of Halle-Wittenberg
Halle/Saale, Sachsen-Anhalt, Germany, 06097
Department of Neurology, TU Dresden
Dresden, Sachsen, Germany, D-01307
Department of Neurology, University of Jena
Jena, Thueringen, Germany, D-07747
Department of Neurology, Humboldt University
Berlin, Germany, 13353
Neurologische Universitätsklinik Bergmannsheil
Bochum, Germany, 44789
Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster
Münster, Germany, 48149
Department of Neurology, DKD HELIOS Klinik
Wiesbaden, Germany, 65191
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Albert C. Ludolph, MD, Prof. University Ulm
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Responsible Party: Albert Christian Ludolph, Prof., Departement of Neurology, University of Ulm
ClinicalTrials.gov Identifier: NCT02306590    
Other Study ID Numbers: LIPCAL-ALS
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Albert Christian Ludolph, Prof., University of Ulm:
amyotrophic lateral sclerosis
survival time
ALS Functional Rating Scale
quality of life
survival
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases