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Amyotrophic Lateral SclerosisLIPCAL-ALS IINCT06280079

Ultra-high-caloric, Fatty Diet in ALS

A study testing Ultra-high-caloric fatty diet in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 23 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
Ultra-high-caloric fatty diet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
23 sitesGermany
Study dates
2 Jul 2024to 5 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria
  • Disease duration (onset of first paresis or bulbar symptoms) < 24 months
  • Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit)
  • Age ≥18 years.
  • Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion
  • Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion
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  • Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion
  • Capable of thoroughly understanding all information given
  • full written informed consent according to good clinical practice

Who cannot join

  • Previous participation in another interventional study involving an active treatment within the preceding 4 weeks
  • Tracheostomy or continuous permanent ventilator dependence (>22 hours per day)
  • Pregnancy or breastfeeding
  • Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
  • Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment.
  • Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.
  • Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • RWTH Aachen

    Aachen

  • Charité Universitätsmedizin Berlin

    Berlin

  • University Clinic Bochum

    Bochum

  • University Clinic Bonn

    Bonn

  • Technical University Dresden

    Dresden

  • University Clinic Erlangen

    Erlangen

  • Alfried Krupp Krankenhaus Essen

    Essen

  • University Clinic Göttingen

    Göttingen

  • University Clinic Halle

    Halle

  • Hannover Medical School

    Hanover

  • University Clinic Jena

    Jena

  • DRK Clinic Kassel

    Kassel

  • Klinikum Kempten

    Kempten

  • University Clinic Leipzig

    Leipzig

  • University Clinic Lübeck

    Lübeck

  • Diakonissenkrankenhaus Mannheim

    Mannheim

  • Technical University Munich

    Munich

  • University Clinic Münster

    Münster

  • University Clinic Regensburg

    Regensburg

  • University Clinic Rostock

    Rostock

  • University of Ulm

    Ulm

  • DKD HELIOS Clinic Wiesbaden

    Wiesbaden

  • University Clinic Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: Efficacy, Safety, and Tolerability of Ultra-high-caloric, Fatty Diet (UFD) in Amyotrophic Lateral Sclerosis (ALS)

This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).

Read the detailed description

ALS is a fatal neurodegenerative disease, leading to progressive paralysis of voluntarily innervated muscles and to death caused by respiratory failure after a mean disease duration of 2-4 years.The proposed study aims at improving survival of ALS patients by targeting metabolic parameters. ALS patients feature an intrinsic hypermetabolism as signified by an increased resting energy expenditure, which significantly contributes to progressive weight loss and cachexia. The extent of weight loss is an independent prognostic factor for survival in ALS. It has been shown that survival of ALS mice can be prolonged by applying a high-caloric nutrition. Furthermore, ALS patients feature distinct alterations of lipid metabolism, and various studies suggest a protective effect of high triglyceride serum levels.

In the precursor-study LIPCAL-ALS-I, a randomized, placebo-controlled, multicenter trial, evaluating the effects of a high-caloric fatty diet (HCFD), the primary endpoint (survival in the whole study population) was missed. However, post-hoc analysis revealed showed that HCFD (1) increased survival and reduced weight loss in normal to fast-progressing patients (patients with a functional decline measured by ALS Functional Rating Scale Revised) above the median at baseline; p=0.02), (2) slowed down functional decline (measured by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised) in the whole study population (p<0.0125), and (3) lowered neurofilament light chain (NfL) serum levels as a prognostic biomarker in the whole study population (p=0.0225).

Therefore, this study aims at prolonging survival in ALS patients by applying 1.5-fold dosage of the same intervention as in LIPCAL-ALS I in a larger number of patients, excluding patients with slow disease progression.

Being tested
Ultra-high-caloric fatty diet, Placebo
Keywords
Amyotrophic Lateral Sclerosis, High-caloric, high-fat nutrition, Survival, Randomized controlled trial
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultra-high-caloric fatty dietDietary supplement

    100% fat (70g), saturated fatty acids 7,5g, monounsaturated fatty acids 42,6g, polyunsaturated fatty acids 19,9g, long-chain fatty acids 100%, ratio omega-6 to omega-3 fatty acids 5:1, protein 0g, carbohydrates 0g, fiber 0g

  • PlaceboOther

    <5% fat (<3,5g), protein 0g, carbohydrates 0g, fiber 0g

Study groups in NCT06280079
Study groupRoleWhat they receive
Ultra-high-caloric fatty dietExperimentalultra-high-caloric, high-fat, fluid nutritional supplement oral intake of 4 times 35 ml per day in addition to normal food intake, corresponding to +630 kcal and +70g fat per day
Receives: Dietary Supplement: Ultra-high-caloric fatty diet
PlaceboPlacebo comparatorplacebo, fluid nutritional supplement oral intake of 4 times 35 ml per day in addition to normal food intake, corresponding to +50 kcal and +3,5g fat per day
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (>22 hours per day)

    Measured: 18 months

Secondary outcomes (16)

  1. Amyotrophic Lateral Sclerosis Functional Rating Scale Revised

    Change per month of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised

    Measured: 18 months

  2. Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale

    Change per month of Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale

    Measured: 18 months

  3. Individual Quality of Life

    Change of Euro Quality of Life 5D 5L (EQ-5D-5L) compared to baseline

    Measured: 18 months

  4. Slow vital capacity

    Change of slow vital capacity compared to baseline

    Measured: 18 months

  5. Survival

    Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (>22 hours per day)

    Measured: 6 months

  6. Survival

    Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (>22 hours per day)

    Measured: 12 months

  7. Time to death

    Time from date of randomization until date of death

    Measured: 18 months

  8. Time to tracheostomy

    Time from date of randomization until date of tracheostomy

    Measured: 18 months

  9. Time to permanent continous ventilator dependence

    Time from date of randomization to permanent continous ventilator dependence (>22 hours per day)

    Measured: 18 month

  10. Ventilation assistance-free survival

    Time from date of randomization until implementation of mechanical ventilation

    Measured: 18 months

  11. Body Mass Index

    Change of body mass index compared to baseline

    Measured: 18 months

  12. Council of Nutrition Appetite Questionnaire

    Change of Council of Nutrition Appetite Questionnaire sum score compared to baseline

    Measured: 18 months

  13. Eating Habits

    Change of Ulm Nutrition Questionnaire compared to baseline; qualitative changes on a descriptional level (the questionnaire has no sum score); the score is meant to detect changes of eating habits and has been used in the precursor study LIPCAL-ALS I (see doi: 10.1002/ana.25661).

    Measured: 18 months

  14. Neurofilament light chain

    Change of neurofilament light chain serum levels compared to baseline

    Measured: 18 months

  15. Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model

    Difference between observed and predicted decrease of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (measured as points lost per month), based on the a prediction model, which estimates disease progression based on neurofilament light chain serum baseline levels

    Measured: 18 months

  16. Neurofilament Assess Score

    Difference between observed and predicted survival based on the Neurofilament Assess Score, a score estimating survival based on the neurofilament light chain serum baseline levels

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start2 Jul 2024
  3. Primary completion5 Apr 2028 (estimated)
  4. Study completion5 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280079
Sponsor's protocol ID
LIPCAL-ALS II 2.01
Acronym
LIPCAL-ALS II
Status last verified
Oct 2026
First submitted
19 Feb 2024
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures) as well as the study protocol will be available.

Questions about this trial

What is this clinical trial studying?

A study testing Ultra-high-caloric fatty diet in people with Amyotrophic Lateral Sclerosis, run by University of Ulm at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06280079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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