20 Healthy subjects in a good state of health comparable by age and sex with the other selected groups

20 subjects affected by Amyotrophic Lateral Sclerosis with Bulbar onset, comparable by age and sex with the other selected groups

20 subjects affected by Amyotrophic Lateral Sclerosis with Spinal onset, comparable by age and sex with the other selected groups

20 subjects affected by Parkinson's Disease comparable by age and sex with the other selected groups

20 subjects affected by Alzheimer's Disease comparable by age and sex with the other selected groups

The biospecimen collected in this project will be saliva. The contained nucleic acids will not be specifically analysed

Amyotrophic Lateral Sclerosis

Only male subjects will be included in order to prevent biases due to the hormone's influences

Saliva collection and processing to all the enrolled subjects and consecutive Raman analysis of the biological fluid. Statistical processing of the collected data.

Raman analysis of saliva with data collection and analysis

Istituto Auxologico Italiano

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Salivary Biomarker Discovery by Raman Spectroscopy in ALS (SalivALS)

Salivary Raman Fingerprint as Biomarker for the Diagnosis of Amyotrophic Lateral Sclerosis

Raman spectroscopy will be used to identify a new salivary biomarker for the fast discrimination between healthy subjects and patients affected by ALS. Saliva samples will be collected and processed without any labeling procedure, investigating the overall salivary biochemistry of the two investigated groups. Using multivariate analysis on the collected data we will be able to create a classification model that can discriminate ALS signature from healthy subjects.

The Raman data collected from ALS patients will be compared with the one obtained from patients affected by Alzheimer's and Parkinson's disease, validating our methodology as differential diagnostic tool for the discrimination of ALS from other neurological diseases

The intra-group analysis of recruited spinal and bulbar ALS patients will reveal the Raman fingerprint associated to the specific pathological subtype. This result will be important for the stratification of ALS patients after the ALS diagnosis.

Raman data related to the ALS group will be correlated with clinical and paraclinical data, validating in this way our methodology. Collected data will be correlated primarily with factors that can alterate the biochemical composition of saliva including age, smoking habit, time before the last meal, time before teeth brushing, percutaneous endoscopic gastrostomy, mechanical ventilation and others. Consequently the same data will be analysed finding correlations with ALS-FRS (Amyotrophic Lateral Sclerosis - Functional Rating Scale), WHO-QOL (World of Health Organization - Quality of Life), blood analysis outcome, time from the diagnosis and other

Fondazione Don Carlo Gnocchi Onlus

intake of 405 kcal (45g fat) per day in addition to normal food intake

intake of 810 kcal (90g fat) per day in addition to normal food intake

intake of 900 kcal (111.4g carbohydrate, 34.9g fat, 36.0g protein) in addition to normal food intake

high-caloric fatty diet

ultra-high-caloric fatty diet

ultra-high-caloric carbohydrate-rich diet

University of Ulm, Department of Neurology

Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)

Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)

Incidence of Adverse Events and Serious Adverse Events

Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations

Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite

Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score

taste of intervention (visual analogous scale); values 1-9, higher values mean better taste

change of body weight compared to baseline

change of neurofilament light chains (NfL) in serum

Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)

change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment

Data will be available beginning 3 months and ending 5 years following article publication. Data will be shard with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data acess agreement. The study protocol will be available for 5 years at htpps://www.uniklinik-ulm.de/neurologie.html.

Albert Christian Ludolph, Prof.

Prof. Dr.

Nutritia GmbH, 91052 Erlangen, Germany

Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates

KetoCal

Johns Hopkins ALS Clinic

Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

Safety and Tolerability of the Ketogenic Diet in ALS

Vinay Chaudhry

Professor

Johns Hopkins University

Nutricia North America

Cornell University

Subjects having either definite or probable ALS by El Escorial Criteria.

Subjects having been diagnosed with a non-ALS neurological condition

Subjects in good health without any neurological conditions

Neurodegenerative Diseases

MDA/ALS Center of Hope

Quantitative Measurement of Nutritional Substrate Utilization in Patients With Amyotrophic Lateral Sclerosis (ALS)

Quantitative Measurement of Nutritional Substrate Utilization in Patients With ALS

Indirect calorimetry will be used to determine how many calories you are burning and how much of your total calories burned are fats.

amyotrophic lateral sclerosis/carbohydrate

Salivary Biomarker Discovery by Raman Spectroscopy in ALS (SalivALS)

Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)

Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

Quantitative Measurement of Nutritional Substrate Utilization in Patients With Amyotrophic Lateral Sclerosis (ALS)

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