In the laboratory, we have had an ongoing program that is designed to identify naturally occurring, non-toxic, readily available compounds capable of increasing the amount of IKAP protein in individuals with FD. Our latest discovery is that two compounds commonly found in soy, genistein and daidzein, correct the aberrant splicing of IKAP RNA that occurs because of the FD mutation. These compounds very effectively increase the amount of IKAP protein produced in cells of individuals with FD. We have also observed that genistein affects the RNA splicing process in neuronal cells (where the effects of FD are manifested the most), which is very significant. In addition, the combined treatment of FD-derived cells with genistein and EGCG results in an approximately five-fold increase in the amount of functional IKAP RNA produced in the FD-derived cells. While the amount of IKAP RNA produced in FD-derived cells is important, what really matters is how much of the functional IKAP protein is produced in these treated cells. We have observed that the combined treatment of FD-derived cells with genistein and EGCG results in the production of IKAP protein levels that are the equivalent to that produced in normal human cells.



As has been our tradition, before introducing new compounds as potential therapies to the FD community, the study compounds are introduced into a local population, where the effect can be closely monitored. This is an important aspect of the work, as an observation made in the laboratory may or may not translate into a real biological effect in individuals. The individuals with FD who were the first to try the genistein- and daidzein-containing “Genistein Soy Complex” pills produced by Source Naturals were all following our other recommendations when they started on this new treatment. Many of the parents reported that their children had no crises, had far more energy and were able to function better in school. No side effects were seen. We do not know if the same dramatic improvement will be observed in patients who are not following the other therapeutic approaches that we have developed.

The manufacturer’s recommended dose of this product, as listed on the bottle, is two 1000 mg tablets twice daily. We have found that the ingestion of one pill daily (half in the AM and half in the PM) together with a dose of green tea, is sufficient to mediate a positive effect in those with FD. Individuals with FD who weigh between 20 and 100 pounds have observed a benefit from this dose. To achieve maximum benefit, it is critical that the soy complex be taken together with the green tea. We did not see any benefit to taking in excess of one soy complex pill each day and we therefore recommend that the dose of one pill daily not be exceeded.

For those who have difficulty with ingesting a pill, the Source Naturals Genistein Soy Complex also comes in a powder form. The same daily dose, 1000 mg, is recommended, split into two doses of 500 mg each and taken together with the green tea. One dose of 500 mg of the powder is equal to 1/5 of a teaspoon (tsp.). A baker’s measuring spoon must be used to accurately prepare a dose. Since measuring spoons usually come in sizes such as ½ tsp., ¼ tsp., 1/8 tsp., etc., you can either give a little less than a level ¼ tsp. for each dose, or give a level 1/8 tsp. for one dose and a level ¼ tsp. for the 2nd dose, which is almost exactly the same as two 1/5 tsp. doses. Obviously, before introducing any new supplement, you should discuss its use with the physician that cares for your child.
Publication: Nutraceutical-mediated restoration of wild-type levels of IKBKAP-encoded IKAP protein in familial dysautonomia-derived cells (PDF)