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

Amyotrophic Lateral Sclerosis Clinical Trial

— JERN_ALS  

Official title:

Observational Study for Evaluating the Potential of Diet and Food Components as Disease Modifiers in Amyotrophic Lateral Sclerosis (JERN_ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572479
• Other study ID #: H01_15
• Status: Completed
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2015
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Dietary Habits
• Disorder of Fatty Acid Metabolism
• Lipid Metabolism Disorders
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
Germany	Jena University Hospital, Hans Berger Department of Neurology	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical neurological examination	ALS functional rating scale-revised (ALSFRS-R); - the parameter will be assessed every three months through study completion	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	Blood lipids	Total cholesterol, HDL-cholesterol, LCL-cholesterol, triacylglycerides; - the parameter will be assessed every six months through study completion	through study completion, an average of 1 year
Secondary	Inflammatory parameter	c-reactive protein; - the parameter will be assessed every six months through study completion	through study completion, an average of 1 year
Secondary	Metabolic serum parameters	glycated hemoglobin HbA1C; - the parameter will be assessed every six months through study completion	through study completion, an average of 1 year
Secondary	Clinical neurological examination, part II	EQ5D-5L (population based QoL questionnaire); - the parameter will be assessed every six months through study completion	through study completion, an average of 1 year