Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)
JERN_ALS
Observational Study for Evaluating the Potential of Diet and Food Components as Disease Modifiers in Amyotrophic Lateral Sclerosis (JERN_ALS)
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 6, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 7, 2019
September 1, 2015
3 years
October 6, 2015
March 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Nutrient intake by diet
through study completion, an average of 1 year
Fatty acid distribution in erythrocyte lipids
through study completion, an average of 1 year
Blood lipids
through study completion, an average of 1 year
Inflammatory parameter
through study completion, an average of 1 year
Metabolic serum parameters
through study completion, an average of 1 year
- +1 more secondary outcomes
Eligibility Criteria
ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
You may qualify if:
- 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.
You may not qualify if:
- patient's request or if patient compliance with the study protocol is doubtful
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Jenalead
- Jena University Hospitalcollaborator
Study Sites (1)
Jena University Hospital, Hans Berger Department of Neurology
Jena, Thuringia, 07743, Germany
Biospecimen
Blood sampling every six months (1x 9mL Sarstedt monovette)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 6, 2015
First Posted
October 9, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
March 7, 2019
Record last verified: 2015-09