ABSTRACT
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 6g/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 6g of fish protein hydrolysate (Amizate®) was safe and suitable for supplementing the diets of malnourished children.
Subject(s)
Child Nutrition Disorders/diet therapy , Dietary Supplements/adverse effects , Fish Products/adverse effects , Fish Proteins/adverse effects , Protein Hydrolysates/administration & dosage , Protein Hydrolysates/adverse effects , Animals , Child , Diet/adverse effects , Double-Blind Method , Female , Fish Proteins/administration & dosage , Humans , MaleABSTRACT
UNLABELLED: Protein hydrolysates are good nutritional supplements as their bioactive ingredients can be easily absorbed and utilized for various metabolic activities. A fish protein hydrolysate (Amizate), prepared by a unique process of hydrolysis has the advantage of high di/tri peptide content (<10 kDa) along with essential and non essential amino acids, micronutrients and vitamins. The effect of Amizate on malnourished children (6-8 years, a total of 438) of Grade I and II (Gomez's classification) with respect to immunoglobulins, CD4/CD8 ratios and hemoglobin was examined. Measurement of these parameters during the user trial study (at the beginning and the end after 4 months) indicated that the levels of the immunological parameters were not significantly altered by the Amizate treatment. The values of immunoglobulins and CD4/CD8 ratios of malnourished children (India) are in the normal range and are in accordance with the reported values of various ethnic groups. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12291-011-0145-z) contains supplementary material, which is available to authorized users.
