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

Amyotrophic Lateral Sclerosis Clinical Trial

— TOLCAL  

Official title:

Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172792
• Other study ID #: TOLCAL
• Status: Completed
• Phase: Phase 1
• Start date: November 26, 2019
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2021
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Dietary Supplement:
• high-caloric fatty diet
see arm/group description
• ultra-high-caloric fatty diet
see arm/group description
• ultra-high-caloric carbohydrate-rich diet
see arm/group description

Locations

Country	Name	City	State
Germany	University of Ulm, Department of Neurology	Ulm	Baden-Wurttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Albert Christian Ludolph, Prof.	Nutritia GmbH, 91052 Erlangen, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ludolph A, Drory V, Hardiman O, Nakano I, Ravits J, Robberecht W, Shefner J; WFN Research Group On ALS/MND. A revision of the El Escorial criteria - 2015. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(5-6):291-2. doi: 10.3109/21678421.2015.1049183. Epub 2015 Jun 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events and Serious Adverse Events	Incidence of Adverse Events and Serious Adverse Events	4 weeks
Primary	Laboratory values	Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations	4 weeks
Secondary	Appetite	Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite	2 weeks; 4 weeks
Secondary	Eating Habits	Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score	2 weeks; 4 weeks
Secondary	Taste of Intervention	taste of intervention (visual analogous scale); values 1-9, higher values mean better taste	2 weeks; 4 weeks
Secondary	Body Weight	change of body weight compared to baseline	2 weeks; 4 weeks
Secondary	Biomarkers	change of neurofilament light chains (NfL) in serum	4 weeks
Secondary	Adverse Events and Serious Adverse Events	Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)	6 weeks
Secondary	ALSFRS-R	change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment	4 weeks