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Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS) (JERN_ALS)

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ClinicalTrials.gov Identifier: NCT02572479
Recruitment Status : Unknown
Verified September 2015 by Christine Dawczynski,PhD, University of Jena.
Recruitment status was:  Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Jena University Hospital
Information provided by (Responsible Party):
Christine Dawczynski,PhD, University of Jena

Brief 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.

Condition or disease
Amyotrophic Lateral Sclerosis Dietary Habits Disorder of Fatty Acid Metabolism

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 Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study for Evaluating the Potential of Diet and Food Components as Disease Modifiers in Amyotrophic Lateral Sclerosis (JERN_ALS)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018





Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Nutrient intake by diet [ Time Frame: through study completion, an average of 1 year ]

    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

  2. Fatty acid distribution in erythrocyte lipids [ Time Frame: through study completion, an average of 1 year ]
    • 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

  3. Blood lipids [ Time Frame: through study completion, an average of 1 year ]

    Total cholesterol, HDL-cholesterol, LCL-cholesterol, triacylglycerides

    - the parameter will be assessed every six months through study completion


  4. Inflammatory parameter [ Time Frame: through study completion, an average of 1 year ]

    c-reactive protein

    - the parameter will be assessed every six months through study completion


  5. Metabolic serum parameters [ Time Frame: through study completion, an average of 1 year ]

    glycated hemoglobin HbA1C

    - the parameter will be assessed every six months through study completion


  6. Clinical neurological examination, part II [ Time Frame: through study completion, an average of 1 year ]

    EQ5D-5L (population based QoL questionnaire)

    - the parameter will be assessed every six months through study completion



Biospecimen Retention:   Samples Without DNA
Blood sampling every six months (1x 9mL Sarstedt monovette)


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • patient's request or if patient compliance with the study protocol is doubtful

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572479


Locations
Germany
Jena University Hospital, Hans Berger Department of Neurology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Jena University Hospital
Investigators
Principal Investigator: Julian Grosskreutz, PhD Jena University Hospital, Hans Berger Department of Neurology
Principal Investigator: Christine Dawczynski, PhD University of Jena, Department of Nutritional Biochemistry and Physiology
Principal Investigator: Stefan Lorkowski, Professor University of Jena, Department of Nutritional Biochemistry and Physiology

Responsible Party: Christine Dawczynski,PhD, PhD, University of Jena
ClinicalTrials.gov Identifier: NCT02572479     History of Changes
Other Study ID Numbers: H01_15
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: September 2015

Keywords provided by Christine Dawczynski,PhD, University of Jena:
fatty acids, amyotrophic lateral sclerosis, nutrient status

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lipid Metabolism Disorders
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases