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Ultra-high-caloric, Fatty Diet in ALS

ConditionAmyotrophic Lateral Sclerosis
Trial statusActive, not recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ulm

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultra-high-caloric fatty diet

    Dietary 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

  • Placebo

    Other intervention

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

Treatment groups

399 Participants
are divided into 2 treatment groups
Group A: Ultra-high-caloric fatty dietExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival

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

Time frame
18 months

Secondary outcomes

1

Amyotrophic Lateral Sclerosis Functional Rating Scale Revised

Change per month of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised

Time frame
18 months
2

Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale

Change per month of Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale

Time frame
18 months
3

Individual Quality of Life

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

Time frame
18 months
4

Slow vital capacity

Change of slow vital capacity compared to baseline

Time frame
18 months

Other outcomes

1

Microtubule-associated protein 2 in serum

change of Microtubule-associated protein 2 levels in serum compared to baseline

Time frame
18 months
2

Microtubule-associated protein 2 in cerebrospinal fluid

change of microtubule-associated protein 2 levels in cerebrospinal fluid compared to baseline

Time frame
18 months
3

Ubiquitin carboxy-terminal hydrolase L1 in serum

change of ubiquitin carboxy-terminal hydrolase L1 levels in serum compared to baseline

Time frame
18 months
4

Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid

change of ubiquitin carboxy-terminal hydrolase L1 levels in cerebrospinal fluid compared to baseline

Time frame
18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ulm

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: