Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
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ClinicalTrials.gov Identifier: NCT02306590 |
Recruitment Status :
Completed
First Posted : December 3, 2014
Last Update Posted : February 26, 2019
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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 |
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Amyotrophic Lateral Sclerosis | Dietary Supplement: Calogen Dietary Supplement: Placebo | Not Applicable |
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
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Dietary Supplement: Calogen |
Placebo Comparator: Placebo
Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care
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Dietary Supplement: Placebo |
- Survival in ALS-patients with study intervention compared to placebo [ Time Frame: 18 months ]
- Change of total ALS functional rating scale revised (ALSFRS-R) [ Time Frame: 18 months ]
- Change of individual quality of life (SEIQoL) [ Time Frame: 18 months ]
- Change of the slow vital capacity (sVC) [ Time Frame: 18 months ]
- Time to tracheostomy or death (combined) [ Time Frame: 18 months ]
- Change of Body Mass Index (BMI) [ Time Frame: 18 months ]
- 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 |
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.

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
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 |
Principal Investigator: | Albert C. Ludolph, MD, Prof. | University Ulm |
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 |
amyotrophic lateral sclerosis survival time ALS Functional Rating Scale quality of life survival |
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 |