For the group of the date 1, Diagnosed autistic patients will be given three pieces of Dates will be given on daily basis for 12 weeks as follow: Three pieces (each about 10 -15 gm), of Dates, will be taken with breakfast or between breakfast and lunch as a test dose daily (without drinking any tea after it by at least one hour).

For the group of the date 2, Diagnosed autistic patients matched for age and sex will be given five pieces of Dates will be given on daily basis for 12 weeks as follow: five pieces (each about 10 -15 gm), of Dates, will be taken with breakfast or between breakfast and lunch as a test dose daily (without drinking any tea after it by at least one hour).

Group 3 (no- Dates fruit group): Diagnosed autistic patients matched for age and sex will not receive any dates

Autistic Spectrum Disorder

Two groups will receive Dates; The number per group is dependant on the child age. For children aged 3-6 years; they will receive the minimum numbers of dates (3 pieces). For children aged more than 6-12 years will receive 5 pieces of Dates the choice of the minimum numbers of dates (3 pieces) in this current trial is based on a study that was done by Al Jaouni and his colleagues, 2019 which proved the effects of three pieces of Ajwa on infection, hospitalization, and survival among 26 pediatric cancer patients in a university hospital; for which their treatment outcome was improved due to their intake of this amount of Ajwa during their standard treatment

Dates fruit as functional Food

Behavioral modification applied to the autistic children that is based on applied behavior analysis (ABA), a widely accepted approach that tracks a child's progress in improving his or her skills. We use Positive Behavioral and Support (PBS)

behavioral modification and stimulation

The nutritional education sessions are based on educating parents on providing their autistic children with a nutritious, balanced diet. Because children with ASD often have restricted diets as well as difficulty sitting through meal times, they may not be getting all the nutrients they need, particularly calcium and protein

nutritional Guidance

National Research Centre

Dates as a Functional Food for Autism

Evaluating Dates as a Functional Food for Autism Via Its Prebiotic Effect, Modulation of Anti-Inflammatory and Anti-Oxidative Activity.

comparing blood levels of three oxidative markers; Malondialdehyde (MDA), glutathione peroxidase (GPX1) and superoxide dismutase (SOD) in children with autism for the three proposed regimen. Measuring the difference pre and three months after the intervention, before and six months after the intervention

Through the quantitative PCR (qPCR) for the change in the presence and absence of the targeted bacterial subgroups (including Bifidobacterium, lactobacillus, Clostridium, Sutterella)

by DNA extraction kits of the fecal samples and Real-time PCR before and after interventions we will measure the change in the presence of the probiotics before and after the intervention

Mental Development, Psychomotor Development and Behavior Rating will be assessed by using the "Bailey Scales of Infant and Toddler Development", the cognitive, language, and motor abilities will be assessed; as well as social-emotional and adaptive behavior. Mental and psychomotor developmental quotients and mental age will be scored as well as the behavioral profile. The Bailey Screening Test is an Observation Checklist for 5 domains of development (cognitive, language, motor, social-emotional, & adaptive behavior).

comparing changes the severity of autism as a result of interventions according Diagnostic and statistical manual of mental disorders, 5th ed. (DSM-V) criteria it measure specific ASD symptom severity All core features of ASD are included: socialisation impairments, communication deficits and repetitive or restricted interests, including sensory abnormalities. After a period of interactive play, the observer rates the child's behaviour, comparing it to that of his/her age group. Each item is given a numerical score of '0' (indicating no impairment), '1' (indicating mild impairment), or '2' (indicating severe impairment)

comparing changes the severity of autism as a result of interventions according to CARS.Each item on the Clinician-Rated Severity of Autism Spectrum and Social Communication Disorders measure is rated on a 4-point scale (Level 0=None; Level 1=Mild/Requiring support; Level 2=Moderate/Requiring SUBSTANTIAL support; and Level 3=Severe/Requiring VERY SUBSTANTIAL support).

comparing changes on eating behaviors as assessed by the 24 hours intake and food pattern. Dietary intake is difficult to measure, and any single method cannot assess dietary exposure perfectly. The 24HR, and FFQ are subjective estimates. Recently, it has been suggested that a combination of methods, such as the FFQ with 24HR be used to obtain more accurate estimates of dietary intakes than that of individual methods. They are widely used as the primary dietary assessment tool in epidemiological studies..

all IPD that underlie results in a publication will be shared

Prof.Dr. Ammal Mokhtar Metwally

Principal Investigator

National Research Center, Egypt

Dates and their constituents show a role in disease prevention through anti-oxidant, anti-inflammatory, anti-bacterial activity. Dates are considered a staple food item in the Middle East and North Africa and are also imported in Europe, the UK, and the USA. (12).
Dates' therapeutic effect in the management of the disease via its anti-oxidant, anti-inflammatory effect and for the sake of autistic children, is worthy to point and essential to evaluate Dates as a good remedy for autistic children because it is inexpensive and easy to access.

P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.

Toxicity

Safety Issues

P2Et extract

Hospital Universitario San Ignacio

Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

Open-label, Single Arm, Phase 1 Study to Assess the Safety of P2Et Extract Obtained From Caesalpinia Spinosa, in Voluntary Subjects in Colombia

Identification of the maximum dose toxicity

Change between baseline immunological profile percentage and end of the treatment immunological profile percentage with its respective mean, median, standard deviation and range.

Pontificia Universidad Javeriana

Open-label, single arm, Phase 1 study. 24 participants are anticipated, assuming that 6 participants are recruited in each of the levels of dose titration based on the 3 +3 design.

Daidzin 80 mg, single dose, oral administration (4 capsules of Super-Absorbable Soy Isoflavones®).
Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml.

Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml.

Healthy

Super-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein).

Daidzin

Alcohol

Parc de Salut Mar.

Interaction Between a Natural Aldehyde Dehydrogenase 2 (ALDH2) Inhibitor and Alcohol

Human Pharmacology Study to Evaluate the Interaction Between a Natural Inhibitor of Aldehyde Dehydrogenase 2 (ALDH2) and Alcohol in Healthy Volunteers. Pilot Clinical Trial

Calculation of AUC for blood alcohol concentrations

Vital signs (heart rate, blood pressure, respiration rate, oral and facial temperature) and adverse effects measured by visual analogue scales (nausea, vomiting, vertigo, dizziness, headache, breathing difficulty, facial flushing)

Drunkenness and euphoria will be measured by a visual analogue scale (VAS).

Calculation of AUC of plasmatic concentrations of daidzein, genistein and equol

Collection of adverse events spontaneously reported by the participants and/or observed by the investigators.

Subjective effects will be measured with the Addiction Research Center Inventory (ARCI)

Calculation of elimination half-life from blood ethanol concentrations

Calculation of elimination half-life of plasmatic concentrations of daidzein, genistein and equol

Urine will be collected in the following periods:0-2h,2-8h,8-14h,14-24 h after administration. Concentrations of daidzein, genistein and equol will be measured

Parc de Salut Mar

Ministerio de Sanidad, Servicios Sociales e Igualdad

Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

Multiple System Atrophy

EGCG as putative neuroprotective agent

Placebo

Fox trial finder of the Michael J Fox foundation

Neurology Department, Ludwig-Maximilians University

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus für Bewegungsstörungen

Charité - Universitätsmedizin Berlin

Technische Universität Dresden

Heinrich-Heine-Universität, Neurologische Klinik

Paracelsus-Elena-Klinik Kassel

Universität Leipzig

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Philipps Universität Marburg

Eberhard Karls Universität Tübingen

Universitätsklinikum Ulm

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Double-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)

To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in clinical global impression

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral atrophy (3D MP-RAGE MRI volumetry, 3D FLAIR)

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral iron deposition in pons and striatum (T2* MRI)

Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time)

To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6 to V7) to explore possible symptomatic effects.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in Albumine, total protein, ferritin, iron, transferrin

polyphenol/muntah

Dates as a Functional Food for Autism

Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

Interaction Between a Natural Aldehyde Dehydrogenase 2 (ALDH2) Inhibitor and Alcohol

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

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