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

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Dietary Supplement: ultra-high-caloric fatty diet; Dietary Supplement: high-caloric fatty diet; Dietary Supplement: ultra-high-caloric carbohydrate-rich diet

• Registration Number: NCT04172792
• Lead Sponsor: Albert Christian Ludolph, Prof.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2019-11-26
• Status Verified: 2021-04
• Primary Completion: 2021-04-05
• Study Completion: 2021-04-05
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultra-high-caloric fatty diet	ultra-high-caloric fatty diet	intake of 810 kcal (90g fat) per day in addition to normal food intake
high-caloric fatty diet	high-caloric fatty diet	intake of 405 kcal (45g fat) per day in addition to normal food intake
ultra-high-caloric carbohydrate-rich diet	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

Primary Outcome Measures

Name	Time	Method
Adverse Events and Serious Adverse Events	4 weeks	Incidence of Adverse Events and Serious Adverse Events
Laboratory values	4 weeks	Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Ulm, Department of Neurology; 🇩🇪 Ulm, Baden-Wurttemberg, Germany