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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-26

Study Completion Date

2021-04-05

Brief Summary

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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).

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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high-caloric fatty diet

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

Group Type ACTIVE_COMPARATOR

high-caloric fatty diet

Intervention Type DIETARY_SUPPLEMENT

see arm/group description

ultra-high-caloric fatty diet

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

Group Type EXPERIMENTAL

ultra-high-caloric fatty diet

Intervention Type DIETARY_SUPPLEMENT

see arm/group description

ultra-high-caloric carbohydrate-rich diet

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

Group Type EXPERIMENTAL

ultra-high-caloric carbohydrate-rich diet

Intervention Type DIETARY_SUPPLEMENT

see arm/group description

control

normal food intake (no intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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high-caloric fatty diet

see arm/group description

Intervention Type DIETARY_SUPPLEMENT

ultra-high-caloric fatty diet

see arm/group description

Intervention Type DIETARY_SUPPLEMENT

ultra-high-caloric carbohydrate-rich diet

see arm/group description

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No