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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

high-caloric fatty diet

ultra-high-caloric fatty diet

ultra-high-caloric carbohydrate-rich diet

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Ulm, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

high-caloric fatty diet

ultra-high-caloric fatty diet

ultra-high-caloric carbohydrate-rich diet

control

Arm Description

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

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

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

normal food intake (no intervention)

Outcomes

Primary Outcome Measures

Adverse Events and Serious Adverse Events

Incidence of Adverse Events and Serious Adverse Events

Laboratory values

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

Secondary Outcome Measures

Appetite

Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite

Eating Habits

Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score

Taste of Intervention

taste of intervention (visual analogous scale); values 1-9, higher values mean better taste

Body Weight

change of body weight compared to baseline

Biomarkers

change of neurofilament light chains (NfL) in serum

Adverse Events and Serious Adverse Events

Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)

ALSFRS-R

change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment

Full Information

NCT ID

NCT04172792

First Posted

November 19, 2019

Last Updated

April 28, 2021

Sponsor

Albert Christian Ludolph, Prof.

Collaborators

Nutritia GmbH, 91052 Erlangen, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04172792

Brief Title

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

Acronym

TOLCAL

Official Title

Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 26, 2019 (Actual)

Primary Completion Date

April 5, 2021 (Actual)

Study Completion Date

April 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Albert Christian Ludolph, Prof.

Collaborators

Nutritia GmbH, 91052 Erlangen, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

high-caloric fatty diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

ultra-high-caloric fatty diet

Arm Type

Experimental

Arm Description

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

Arm Title

ultra-high-caloric carbohydrate-rich diet

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

normal food intake (no intervention)

Intervention Type

Dietary Supplement

Intervention Name(s)

high-caloric fatty diet

Intervention Description

see arm/group description

Intervention Type

Dietary Supplement

Intervention Name(s)

ultra-high-caloric fatty diet

Intervention Description

see arm/group description

Intervention Type

Dietary Supplement

Intervention Name(s)

ultra-high-caloric carbohydrate-rich diet

Intervention Description

see arm/group description

Primary Outcome Measure Information:

Title

Adverse Events and Serious Adverse Events

Description

Incidence of Adverse Events and Serious Adverse Events

Time Frame

4 weeks

Title

Laboratory values

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Appetite

Description

Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite

Time Frame

2 weeks; 4 weeks

Title

Eating Habits

Description

Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score

Time Frame

2 weeks; 4 weeks

Title

Taste of Intervention

Description

taste of intervention (visual analogous scale); values 1-9, higher values mean better taste

Time Frame

2 weeks; 4 weeks

Title

Body Weight

Description

change of body weight compared to baseline

Time Frame

2 weeks; 4 weeks

Title

Biomarkers

Description

change of neurofilament light chains (NfL) in serum

Time Frame

4 weeks

Title

Adverse Events and Serious Adverse Events

Description

Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)

Time Frame

6 weeks

Title

ALSFRS-R

Description

change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johannes Dorst, PD Dr.

Organizational Affiliation

University of Ulm

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ulm, Department of Neurology

City

Ulm

State/Province

Baden-Wurttemberg

ZIP/Postal Code

89081

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be available beginning 3 months and ending 5 years following article publication. Data will be shard 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. The study protocol will be available for 5 years at htpps://www.uniklinik-ulm.de/neurologie.html.

IPD Sharing Time Frame

3 month after publication until 5 years after publication

IPD Sharing 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.

IPD Sharing URL

https://www.uniklinik-ulm.de/neurologie.html

Citations:

PubMed Identifier

26121170

Citation

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.

Results Reference

background

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

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