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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT04172792
• Date of registration: 19/11/2019
• Prospective Registration: Yes
• Primary sponsor: Albert Christian Ludolph, Prof.
• Public title: Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS) TOLCAL
• Scientific title: Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: November 26, 2019
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04172792
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Johannes Dorst, PD Dr.
• Affiliation: University of Ulm

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Dietary Supplement: ultra-high-caloric fatty diet

Dietary Supplement: high-caloric fatty diet

Dietary Supplement: ultra-high-caloric carbohydrate-rich diet

Primary Outcome(s)

Adverse Events and Serious Adverse Events [Time Frame: 4 weeks]

Laboratory values [Time Frame: 4 weeks]

Secondary Outcome(s)

Appetite [Time Frame: 2 weeks; 4 weeks]

Adverse Events and Serious Adverse Events [Time Frame: 6 weeks]

Biomarkers [Time Frame: 4 weeks]

Eating Habits [Time Frame: 2 weeks; 4 weeks]

Body Weight [Time Frame: 2 weeks; 4 weeks]

Taste of Intervention [Time Frame: 2 weeks; 4 weeks]

ALSFRS-R [Time Frame: 4 weeks]

Secondary ID(s)

TOLCAL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nutritia GmbH, 91052 Erlangen, Germany