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

Albert Christian Ludolph, Prof.

Status and phase: Completed; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Dietary Supplement: ultra-high-caloric carbohydrate-rich diet; Dietary Supplement: ultra-high-caloric fatty diet; Dietary Supplement: high-caloric fatty diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04172792

TOLCAL

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 4 patient groups

high-caloric fatty diet

Active Comparator group

Description:

intake of 405 kcal (45g fat) per day in addition to normal food intake

Treatment:

Dietary Supplement: high-caloric fatty diet

ultra-high-caloric fatty diet

Experimental group

Description:

intake of 810 kcal (90g fat) per day in addition to normal food intake

Treatment:

Dietary Supplement: ultra-high-caloric fatty diet

ultra-high-caloric carbohydrate-rich diet

Experimental group

Description:

intake of 900 kcal (111.4g carbohydrate, 34.9g fat, 36.0g protein) in addition to normal food intake

Treatment:

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

control

No Intervention group

Description:

normal food intake (no intervention)