| CPC A61K 35/20 (2013.01) [A61K 38/018 (2013.01); A61P 25/00 (2018.01)] | 4 Claims |
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1. A method for testing, treating and measuring an improvement in one or more behavioral traits of a subject with Autism or Autism Spectrum Disorder (ASD), said method comprising:
scheduling 8 separate visits with a health care provider for the subject and performing the following steps at each respective scheduled visit:
visit 1 comprises performing an initial assessment of the subject, the initial assessment consisting of receiving current drug/supplement intake information from the subject, wherein the subject is 4.23+/−0.22 years of age;
visit 2 comprises obtaining 4 blood samples from the subject and determining the level of oxidative stress biomarkers, liver function, kidney function and blood cell count; the oxidative stress biomarkers comprising intracellular glutathione levels;
visits 3 and 4 collectively comprise performing 8 behavioral assessments, said visits 3 and 4 each lasting an average of 2 hours and being performed within a 15 day window and no later than 15 days after visit 2; the behavioral assessments consisting of 1) Autism Diagnostic Observation Schedule (ADOS), 2) Childhood Autism Rating Scale (CARS), 3) Autism Diagnostic Interview-Revised (ADI-R), 4) Pre-school Language Scale-Fifth Edition (PLS-5), 5) Social Communication Questionnaire (SCQ), 6) Mullen Scales of Early Learning (MSEL), 7) Vineland Adaptive Behavior Scale, Second Addition (VABS-II) and 8) Child Behavior Checklist 1½-5 LDS (CNCL);
visit 5 comprises recording adverse events about 6-7 weeks following visit 4, the adverse events selected from the group comprising bronchitis, cough, respiratory infection, cold symptoms, constipation, diarrhea, emesis, nausea, fever and rash;
visits 6 and 7 collectively comprise re-performing the 8 behavioral assessments at 12 weeks following visit 4, said visits 6 and 7 each lasting an average of 2 hours and performed within a 15 day window, the assessments performed by the same clinical psychologists who performed the 8 behavioral assessments in weeks 3 and 4, and in the same sequence as performed in weeks 3 and 4;
visit 8 comprises obtaining a further 4 blood samples to separately assess oxidative stress biomarkers, liver function, kidney function and blood cell count, the oxidative stress biomarkers comprising a second intracellular glutathione level measurement, wherein visit 8 is scheduled no later than 7 days after visit 7;
administering a composition comprising whey protein isolate and/or whey protein concentrate to the subject as a treatment beginning at the end of visit 4, in an amount of 0.5 grams/kg for subjects under 20 kg or 10 g for subjects 20 kg and over, and lasting for at least 90 days; and
measuring an improvement in the one or more behavioral traits of the subject as assessed by the Vinland Adaptive Behavior II Composite Scale; wherein the one or more behavioral traits comprise socialization, domestic daily living skills, maladaptive behavior and internalization as determined by the socialization domain, daily living skills domain, maladaptive behavior domain and internalizing subdomain of the Vinland Adaptive Behavior II Composite Scale, respectively.
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