The obtained results are summarized below:

  1. Caffeine and theobromine are not toxic for human fibroblasts cells, even at high concentrations.
  2. Caffeine and theobromine are able to increase MBNL1 in nuclei of DM1 cells in vitro, although their combination allow to further increase MBNL1 levels compared to those for individual compounds, showing a synergistic effect.
  3. When tested in in vivo assays on the Drosophila melanogaster (fruit fly model), significant improvements have been obtained for climbing and flying capacities after feeding the disease flies with Myo-DM in comparison to flies only fed with their standard nutritive media.
  4. These results also correlate with significant improvement in the muscular area quantification of dystrophic flies, closer to the healthy fly strain situation. Myo-DM is able to increase muscle area in dystrophic flies fed with the product.
  5. Regarding to heart dysfunction, DM1 model flies fed with Myo-DM exhibit a very important rescue in almost all the parameters measured in the in vivo model, such as heart period rate, diastolic and systolic intervals and arrhytmicity, among others.

Myo-DM’s daily content on caffeine and theobromine are far below the daily recommended dose by European Food Safety Authority (EFSA), and fulfill the legislation on maximum caffeine content for food supplements in Europe.