Short Chain Fatty Acids Profiles in Amyotrophic Lateral Sclerosis: Longitudinal Effects of Disease and Mediterranean Diet Intervention
Conditions: Amyotrophic Lateral Sclerosis
Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

 
 
 
 
 
TE 74/2022 
 
 
SHORT CHAIN FATTY ACIDS PROFILES IN AMYOTROPHIC LATERAL SCLEROSIS: LONGITUDINAL 
EFFECTS OF DISEASE AND MEDITERRANEAN DIET INTERVENTION 
 
[IMPACT-ALS] 
 
 
 
 
Project period 13/05/2022-12/05/2024 
 
 
 
 
 
                                                                   
 
 
03.09.2025 

     
STUDY PROTOCOL 
SHORT CHAIN FATTY ACIDS PROFILES IN AMYOTROPHIC LATERAL SCLEROSIS: LONGITUDINAL 
EFFECTS OF DISEASE AND MEDITERRANEAN DIET INTERVENTION 
 
WP1 – Creation of the study design, informed consent for patients, definition of the study 
population and approval of the protocol 
 
WP1  
Objectives 
Status 
Deliverables 
Establishment of the study protocol 
Ethics Committee approval 
Completed 
Informed consent form 
Completed 
 
WP2 - Determination of the reagents/materials needed at all stages of the research and 
initiation of procurement procedures 
WP 2  
Objectives 
Status 
Deliverables 
Establishing the reagents and materials needed for the 
research stages (list of necessary materials and equipment, 
with technical specifications) 
Establishing the working protocol for neurophysiological 
exploration 
Completed 
Commencement of procurement procedures, contact with 
suppliers 
Completed 
 
WP3 - Inclusion of patients in the study, initial visit (T0), clinical evaluation, 
neurophysiological evaluation, collection of biological samples and SCFA analysis (SCFAGGYC-
PROF) 
WP 3 
Objectives 
Status 

Deliverables 
Identification of patients with ALS (n=44) and healthy 
controls (similar age and gender; n=40) 
Achieved 
Explaining the objectives of the study and signing the 
informed consent form 
Completed 
Clinical and neurophysiological assessment of each 
ALS patient, with completion of each patient's 
medical record (including ALSFRS-R) 
Completed 
Collection of serum samples 
Completed 
 
WP4 - Reassessment of ALS patients after 6 months (visit T1): clinical and neurophysiological 
evaluation, collection of biological samples and SCFA analysis, and introduction of the diet 
WP 4  
Objectives: Dissemination of research data 
within the grant 
Status 
 
 
 
Deliverables 
Clinical and neurophysiological assessment of 
each ALS patient and application of the dietary 
questionnaire 
Completed 
Collection of serum samples 
Completed 
Completion of the patient's medical file 
Done 
 
Introduction of a dietary plan  
Done 
 
WP5 - Final reassessment of ALS patients (visit T2): clinical assessment, neurophysiological 
assessment, collection of biological samples and SCFA analysis  
WP 5  
Objectives 
Status 
Deliverables 
Clinical and neurophysiological assessment of each 
ALS patient 6 months after introduction of the diet 
Achieved 
Serum sample collection 
Completed 
Completion of each patient's medical file 
Completed 
Neurophysiological report 
Done 
 

 
WP6 - Serum analysis to identify serum SCFA levels 
WP 6  
Objectives: Analysis of stored plasma samples 
using specific analysis kits 
Status 
Deliverables 
Plasma analysis sheets for the SCFAGGYC-PROF 
profile through the analysis of stored plasma 
samples 
Data entry into the database 
Completed 
 
WP 7 - Statistical analysis of collected data 
WP 7  
Objectives: Statistical analysis of clinical, paraclinical and 
electrophysiological data for each ALS patient compared 
to the control group 
Status 
Deliverables 
Discovery of the SCFAGGYC-PROF profile in ALS patients at 
T0 compared to the control group;  
Discovery of the SCFAGGYC-PROF profile P-ALS in T0 and 
T1 evolution;  
Identification of changes in the dynamics of the 
SCFAGGYC-PROF profile in ALS patients comparing T0 with 
T2. 
Achieved