An observational study in Amyotrophic Lateral Sclerosis, Dietary Habits and Disorder of Fatty Acid Metabolism, sponsored by University of Jena. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by University of Jena · Observational
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.
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 50 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
Exclusion Criteria:
Clinical neurological examination
ALS functional rating scale-revised (ALSFRS-R) - the parameter will be assessed every three months through study completion
Time frame: through study completion, an average of 1 year
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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
Inflammatory parameter
c-reactive protein - the parameter will be assessed every six months through study completion
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Jena