Immunotec Inc. has announced the completion of an open-label clinical trial on the use of a cysteine-rich protein isolate in children with autism. Ten children, 3-15 years of age with a diagnosis of autism or autism spectrum disorder (ASD), were supplemented with a non-denatured whey protein isolate (Immunocal(R)). Autism symptoms, behavior, side effects, and treatment adherence were examined, as well as bowel flora. This preliminary study showed the majority of autistic children were able to consume non-denatured whey protein isolate (Immunocal(R)) without adverse effects. Changes in all behavioural parameters showed positive trends but did not reach statistical significance because of the small numbers of patients in this pilot study. The results will provide the basis for a larger placebo controlled double blind study to test the benefits of using whey protein isolate in the treatment of autism. (Kern JK, Grannemann BD, Gutman J, Trivedi MH, Oral Tolerability of Cysteine-Rich Whey Protein Isolate in Autism - A Pilot Study, Journal of the American Nutraceutical Association (JANA), Vol. 11, No. 1, 36-41, 2008.)
Recent evidence suggests that many children with autism have low levels of glutathione in their cells. Non-denatured whey protein can improve
glutathione levels in a variety of diseases and disorders; however, there are anecdotal reports that children with autism may have a worsening of behavior, gastrointestinal (GI) disturbance or related problems after the ingestion of sulfur-rich compounds.
Principle investigator Dr. Janet Kern stated, "We're very optimistic about these pilot results, it makes us very comfortable to pursue larger and
longer-term studies using this strategy."
Immunotec President and CEO Jim Northrop is pleased with these initial results. "Completion of this pilot study will encourage researchers to move on to the next step of studying the role and benefits of our cysteine-rich protein (Immunocal) in children with autistic spectrum disorder. I am proud of Immunotec's commitment to ongoing research and development that continues to validate the confidence and quality in our products."
Immunocal is a cysteine-rich protein isolate derived from non-denatured whey protein. Immunocal(R)/HMS 90(R), is a dietary natural health supplement, developed and marketed worldwide by Immunotec since 1996. Immunocal(R)/HMS 90(R) is a precursor of the major cellular antioxidant glutathione, an element important in maintaining a strong immune system.
About Immunotec Inc.
Immunotec is engaged primarily in the development and marketing of natural health products, dietary supplements, vitamins and personal care
products, many of which are manufactured on its behalf by third parties. Immunotec's products are distributed and sold in the United States and Canada through a network marketing system and in other countries through exclusive distributorship agreements. Immunotec's investment in this study is another manifestation of its ongoing commitment to research and development.
For further information: Media: John H. Molson, Vice-President, Research
& Development, Immunotec Inc., (450) 510-4450, Fax: (450) 424-9993,
[email protected]; Clare Malbon, R&D Dept., (450) 424-9992 Ext 2377