Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers.

A pharmaceutical formulation of genistein, produced as an amorphous solid dispersion by hot melt extrusion (genistein HME), has been developed that can be administered prophylactically to improve outcomes and survival following radiation exposure. Here, genistein HME was evaluated in a phase 1, open-label, single ascending dose (SAD) and multiple single dose (MSD) study enrolling 34 healthy volunteers. In the SAD study, participants were administered a single dose (500, 1000, 2000, or 3000 mg) and in the MSD study, participants were administered a single daily dose for six consecutive days (3000 mg/day).

Enteral feeding enriched with carotenoids normalizes the carotenoid status and reduces oxidative stress in long-term enterally fed patients.

Background & Aims: Circulating carotenoid levels decrease progressively in patients receiving long-term enteral tube feeding with carotenoid-free formulas. Low dietary intake and low blood levels of carotenoids are associated with a higher risk of morbidity and mortality from chronic diseases. The aim of this study was to examine the effects of a low dose carotenoid mixture (3-mg/1500kcal) for 3 months on serum carotenoid levels and oxidative stress in patients receiving long-term enteral nutrition as the sole source of nutrition.