Amyotrophic Lateral SclerosisJERN_ALSNCT02572479
Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)
An observational study of Amyotrophic Lateral Sclerosis and Dietary Habits, run by University of Jena at 1 site in Germany.
Trial summary
The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients complemented by the analysis of fatty acid distribution in erythrocyte lipids. Both data sets are related to disease status and progress. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Dietary Habits, Disorder of Fatty Acid Metabolism
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
Who may be able to join
- ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
- patients should have the ability to comprehend the full nature and purpose of the study, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
Who cannot join
- patient's request or if patient compliance with the study protocol is doubtful
Trial locations and contacts
1 site in 1 country.
Germany1 site
Jena University Hospital, Hans Berger Department of Neurology
Jena, Thuringia, 07743
About this study
Official title: Observational Study for Evaluating the Potential of Diet and Food Components as Disease Modifiers in Amyotrophic Lateral Sclerosis (JERN_ALS)
The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients complemented by the analysis of fatty acid distribution in erythrocyte lipids. Both data sets are related to disease status and progress.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a currently incurable, multifactorial motor neuron disease characterized by upper and lower motor neuron degeneration, skeletal muscle atrophy, paralysis, and death. Multiple mechanisms caused by genetic and environmental factors proposed as responsible for ALS pathogenesis include decreased availability to neurotrophic factors, disturbances in calcium metabolism, increased neuroinflammatory status, cytoskeletal changes, mitochondrial dysfunction, dysfunction of protein degradation, glutamate excitotoxicity, apoptosis and oxidative stress.
Currently, the only available drug to treat ALS is riluzole which slightly prolongs life. Nutritional management has become more important in the treatment of ALS because body mass index and nutritional status seems to be independent, prognostic factors for survival and disease complications. Malnutrition is common in ALS, so caloric supplementation is essential. Additionally, many ALS patients self-medicate with vitamins, herbs, and other dietary supplements.
The objective of the current project is establishing the link between nutritional intake and disease status and progress. In detail, we like to assess if the improved outcomes are associated with specific nutrients, or simply the provision of excess calories. In this context, one of the most promising dietary candidates are polyunsaturated fatty acids (PUFA) and in particular the long-chain n-3 PUFA docosahexaenoic acid. This important structural component in neuronal membranes plays a role in neurogenesis and neuroprotection as well as exerts well-described anti-inflammatory effects in the brain.
The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients (Food Frequency Protocols, FFPs, periodic over 5 days) combined with the analysis of fatty acid distribution in erythrocyte lipids which reflects fatty acid distribution of the consumed fatty or oily foods (time period: approximately the last 2-3 months).
The fatty aids distribution in erythrocyte lipids as well as the nutrient intake calculated by FFPs are related to disease status and progress.
Thus, the current research activities focus on identification of dietary factors that are associated with disease progress or survival to develop beneficial interventions and therapy options.
- Keywords
- fatty acids, amyotrophic lateral sclerosis, nutrient status
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical neurological examination
ALS functional rating scale-revised (ALSFRS-R)
- the parameter will be assessed every three months through study completion
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Nutrient intake by diet
Food Frequency Protocol (FFP) over 5 days before blood sampling (FFP originate from Prodi® 6.4 software; Nutri-Science GmbH, Freiburg, Germany).
Data analysis via Prodi®
- calculation food nutrient profiles originated from the 'Bundeslebensmittelschlüssel'
- calculation of daily energy intake, intake of fat and fatty acids, carbohydrates (individual sugars, dietary fibres), protein and amino acids, vitamins and minerals, sterols, etc.
- the parameter will be assessed every three months through study completion
Measured: through study completion, an average of 1 year
Fatty acid distribution in erythrocyte lipids
- marker for the fatty acid distribution of the consumed fatty or oily foods
- reflect the fatty acid distribution of the consumed fatty or oily foods over the last 2-3 months as well as the endogenous metabolism and conversion of fatty acids
- the parameter will be assessed every six months through study completion
Measured: through study completion, an average of 1 year
Blood lipids
Total cholesterol, HDL-cholesterol, LCL-cholesterol, triacylglycerides
- the parameter will be assessed every six months through study completion
Measured: through study completion, an average of 1 year
Inflammatory parameter
c-reactive protein
- the parameter will be assessed every six months through study completion
Measured: through study completion, an average of 1 year
Metabolic serum parameters
glycated hemoglobin HbA1C
- the parameter will be assessed every six months through study completion
Measured: through study completion, an average of 1 year
Clinical neurological examination, part II
EQ5D-5L (population based QoL questionnaire)
- the parameter will be assessed every six months through study completion
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
- Investigators
- Julian Grosskreutz, PhD, Principal investigator, Jena University Hospital, Hans Berger Department of NeurologyChristine Dawczynski, PhD, Principal investigator, University of Jena, Department of Nutritional Biochemistry and PhysiologyStefan Lorkowski, Professor, Principal investigator, University of Jena, Department of Nutritional Biochemistry and Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572479
- Sponsor's protocol ID
- H01_15
- Acronym
- JERN_ALS
- Status last verified
- Sep 2015
- First submitted
- 6 Oct 2015
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Evaluating the Potential of Diet and Food Components as Disease Modifiers in Amyotrophic Lateral Sclerosis (JERN_ALS)
- ClinicalTrials.gov ID
- NCT02572479
- Acronym / sponsor ID
- JERN_ALS / H01_15
- Keywords
- fatty acids, amyotrophic lateral sclerosis, nutrient status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- Jena University Hospital
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients complemented by the analysis of fatty acid distribution in erythrocyte lipids. Both data sets are related to disease status and progress.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a currently incurable, multifactorial motor neuron disease characterized by upper and lower motor neuron degeneration, skeletal muscle atrophy, paralysis, and death. Multiple mechanisms caused by genetic and environmental factors proposed as responsible for ALS pathogenesis include decreased availability to neurotrophic factors, disturbances in calcium metabolism, increased neuroinflammatory status, cytoskeletal changes, mitochondrial dysfunction, dysfunction of protein degradation, glutamate excitotoxicity, apoptosis and oxidative stress.
Currently, the only available drug to treat ALS is riluzole which slightly prolongs life. Nutritional management has become more important in the treatment of ALS because body mass index and nutritional status seems to be independent, prognostic factors for survival and disease complications. Malnutrition is common in ALS, so caloric supplementation is essential. Additionally, many ALS patients self-medicate with vitamins, herbs, and other dietary supplements.
The objective of the current project is establishing the link between nutritional intake and disease status and progress. In detail, we like to assess if the improved outcomes are associated with specific nutrients, or simply the provision of excess calories. In this context, one of the most promising dietary candidates are polyunsaturated fatty acids (PUFA) and in particular the long-chain n-3 PUFA docosahexaenoic acid. This important structural component in neuronal membranes plays a role in neurogenesis and neuroprotection as well as exerts well-described anti-inflammatory effects in the brain.
The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients (Food Frequency Protocols, FFPs, periodic over 5 days) combined with the analysis of fatty acid distribution in erythrocyte lipids which reflects fatty acid distribution of the consumed fatty or oily foods (time period: approximately the last 2-3 months).
The fatty aids distribution in erythrocyte lipids as well as the nutrient intake calculated by FFPs are related to disease status and progress.
Thus, the current research activities focus on identification of dietary factors that are associated with disease progress or survival to develop beneficial interventions and therapy options.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
Key inclusion criteria (2 listed)
- ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
- patients should have the ability to comprehend the full nature and purpose of the study, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
Key exclusion criteria (1 listed)
- patient's request or if patient compliance with the study protocol is doubtful
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical neurological examination
Time frame: through study completion, an average of 1 year
ALS functional rating scale-revised (ALSFRS-R) - the parameter will be assessed every three months through study completion
6 secondary outcomes
Nutrient intake by diet
Time frame: through study completion, an average of 1 year
Fatty acid distribution in erythrocyte lipids
Time frame: through study completion, an average of 1 year
Blood lipids
Time frame: through study completion, an average of 1 year
Inflammatory parameter
Time frame: through study completion, an average of 1 year
Metabolic serum parameters
Time frame: through study completion, an average of 1 year
Clinical neurological examination, part II
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian Grosskreutz, PhD principal investigator
Jena University Hospital, Hans Berger Department of Neurology
Christine Dawczynski, PhD principal investigator
University of Jena, Department of Nutritional Biochemistry and Physiology
Stefan Lorkowski, Professor principal investigator
University of Jena, Department of Nutritional Biochemistry and Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Dietary Habits, run by University of Jena at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical neurological examination (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.