Who is sponsoring NCT04172792?

NCT04172792 is sponsored by Albert Christian Ludolph, Prof..

What drugs are being tested in NCT04172792?

Interventions in NCT04172792: high-caloric fatty diet, ultra-high-caloric fatty diet, ultra-high-caloric carbohydrate-rich diet.

What condition does NCT04172792 study?

NCT04172792 studies Amyotrophic Lateral Sclerosis.

Is NCT04172792 still recruiting?

NCT04172792 is currently completed. Last updated 29 April 2021.

Last reviewed 2021-04-29 · How we verify

NCT04172792: TOLCAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 29 April 2021

What this trial tests

Phase 1 trial testing high-caloric fatty diet in Amyotrophic Lateral Sclerosis in 64 participants. Completed in 5 April 2021.

Timeline

26 November 2019

Primary endpoint
5 April 2021

5 April 2021

Quick facts

Lead sponsor	Albert Christian Ludolph, Prof.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	64
Start date	26 November 2019
Primary completion	5 April 2021
Estimated completion	5 April 2021
Sites	1 location across Germany

Drugs / interventions tested

high-caloric fatty diet
ultra-high-caloric fatty diet
ultra-high-caloric carbohydrate-rich diet

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Albert Christian Ludolph, Prof.

Who can join

18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Lipid Metabolic Alterations in the ALS-FTD Spectrum of Disorders.
Godoy-Corchuelo JM, Fernández-Beltrán LC, Ali Z, Gil-Moreno MJ, et al · · 2022 · cited 28× · PMID 35625841 · DOI 10.3390/biomedicines10051105
Mitochondria: A Promising Convergent Target for the Treatment of Amyotrophic Lateral Sclerosis.
Cunha-Oliveira T, Montezinho L, Simões RF, Carvalho M, et al · · 2024 · cited 19× · PMID 38334639 · DOI 10.3390/cells13030248
Importance of lipids for upper motor neuron health and disease.
Gunay A, Shin HH, Gozutok O, Gautam M, et al · · 2021 · cited 4× · PMID 33323321 · DOI 10.1016/j.semcdb.2020.11.004
Ketogenic effect of coconut oil in ALS patients.
Carrera-Juliá S, Obrador E, López-Blanch R, Oriol-Caballo M, et al · · 2024 · cited 2× · PMID 39086545 · DOI 10.3389/fnut.2024.1429498
The gut microbiota influences neurodegenerative diseases through the gut-brain axis: molecular mechanisms and effects on immune function.
Yang J, Song X, Yan S, Li Q, et al · · 2025 · PMID 41601624 · DOI 10.3389/fimmu.2025.1739329

Verify or expand the search:

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

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NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting

Other Albert Christian Ludolph, Prof. trials

Trials by the same sponsor.

NCT02671682 — Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04172792 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Albert Christian Ludolph, Prof.
Last refreshed: 29 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04172792.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing