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

University of Ulm

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Calogen

Study type: Interventional

Funder types: Other

Identifiers

NCT02306590

LIPCAL-ALS

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 2 patient groups, including a placebo group

Study Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Calogen

Placebo

Placebo Comparator group

Description:

Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care

Treatment:

Dietary Supplement: Placebo