Amyotrophic Lateral Sclerosis
Conditions
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).
Interventions
DIETARY_SUPPLEMENThigh-caloric fatty diet
see arm/group description
DIETARY_SUPPLEMENTultra-high-caloric fatty diet
see arm/group description
DIETARY_SUPPLEMENTultra-high-caloric carbohydrate-rich diet
see arm/group description
Sponsors
Nutritia GmbH, 91052 Erlangen, Germany
Albert Christian Ludolph, Prof.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Serious Adverse Events | 4 weeks | Incidence of Adverse Events and Serious Adverse Events |
| Laboratory values | 4 weeks | Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating Habits | 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 | 2 weeks; 4 weeks | taste of intervention (visual analogous scale); values 1-9, higher values mean better taste |
| Adverse Events and Serious Adverse Events | 6 weeks | Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished) |
| Biomarkers | 4 weeks | change of neurofilament light chains (NfL) in serum |
| ALSFRS-R | 4 weeks | change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment |
| Body Weight | 2 weeks; 4 weeks | change of body weight compared to baseline |
| Appetite | 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 |
Countries
Germany
Outcome results
None listed