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

Albert Christian Ludolph, Prof.64 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse Events and Serious Adverse Events

Incidence of Adverse Events and Serious Adverse Events

Time frame: 4 weeks

Laboratory values

Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations

Time frame: 4 weeks

Secondary Outcomes

Appetite

Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite

Time frame: 2 weeks; 4 weeks

Eating Habits

Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score

Time frame: 2 weeks; 4 weeks

Taste of Intervention

taste of intervention (visual analogous scale); values 1-9, higher values mean better taste

Time frame: 2 weeks; 4 weeks

Body Weight

change of body weight compared to baseline

Time frame: 2 weeks; 4 weeks

Biomarkers

change of neurofilament light chains (NfL) in serum

Time frame: 4 weeks

Adverse Events and Serious Adverse Events

Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)

Time frame: 6 weeks

ALSFRS-R

change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment

Time frame: 4 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes