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

NCT04172792 | Completed Phase 1

• 1 other identifier: TOLCAL
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (2)

• Adverse Events and Serious Adverse Events

  Incidence of Adverse Events and Serious Adverse Events

  4 weeks

• Laboratory values

  Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations

  4 weeks

Secondary Outcomes (7)

• Appetite

  2 weeks; 4 weeks

• Eating Habits

  2 weeks; 4 weeks

• Taste of Intervention

  2 weeks; 4 weeks

• Body Weight

  2 weeks; 4 weeks

• Biomarkers

  4 weeks

Study Arms (4)

high-caloric fatty diet

ACTIVE COMPARATOR

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

Dietary Supplement: high-caloric fatty diet

ultra-high-caloric fatty diet

EXPERIMENTAL

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

Dietary Supplement: ultra-high-caloric fatty diet

ultra-high-caloric carbohydrate-rich diet

EXPERIMENTAL

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

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

control

NO INTERVENTION

normal food intake (no intervention)

Interventions

high-caloric fatty diet DIETARY_SUPPLEMENT

see arm/group description

high-caloric fatty diet

ultra-high-caloric fatty diet DIETARY_SUPPLEMENT

see arm/group description

ultra-high-caloric fatty diet

ultra-high-caloric carbohydrate-rich diet DIETARY_SUPPLEMENT

see arm/group description

ultra-high-caloric carbohydrate-rich diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Christian Ludolph, Prof.: lead
• Nutritia GmbH, 91052 Erlangen, Germany: collaborator

Study Sites (1)

University of Ulm, Department of Neurology

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Related 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. No abstract available.

  PMID: 26121170 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Johannes Dorst, PD Dr.

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 26, 2019
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 month after publication until 5 years after publication
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data acess agreement.

Locations

DE (1)