Safety evaluation of fish protein hydrolysate supplementation in malnourished children

•Fish protein hydrolysate (Amizate®) was tested for safety in malnourished children.•The 4-month study was randomized, double-blind, and placebo-controlled.•Amizate® was well tolerated, and there were no adverse effects on growth.•Amizate® did not alter hematology, clinical chemistry or urinalysis parameters.•Amizate® is a safe protein source that may be used to supplement the diet.

Amizate® is a proprietary protein hydrolysate preparation derived from Atlantic salmon (Salmo salar) using endogenous hydrolytic enzymes; it contains mostly free amino acids and short peptides, as well as small amounts of micronutrients (i.e., vitamins and minerals). In this study, the safety of supplementation with fish protein hydrolysate (Amizate®) was examined in 438 malnourished children in a randomized, placebo-controlled, double-blind, and parallel study. The children were between the ages of six to eight and met the Gomez classification for mild or moderate malnutrition. They were randomized to receive one of three interventions for four months, including a chocolate drink (control), or Amizate® (3 or 6 g/day) in a chocolate drink. Administration of Amizate® was well-tolerated, with no adverse events reported. Growth (i.e., body weight gain, changes in height, and body mass index) was not negatively impacted by administration of Amizate®, and routine biochemical analysis of blood and urine samples did not reveal any abnormalities that were attributable to the intervention. Findings from this study demonstrate that daily consumption of 3 or 6 g of fish protein hydrolysate (Amizate®) was safe and suitable for supplementing the diets of malnourished children.