title: Safety evaluation of fish protein hydrolysate supplementation in malnourished children.
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.
authors.affiliation: Zymtech Production AS, Industriparken, NO-2665, Lesja, Norway.
authors.forename: Knut Olav
authors.initials: KO
authors.lastname: Nesse
authors.affiliation: Consortium Clinical Research Pvt. Ltd., No. 9/41, Sri Kalki Gardens, Sugunapuram, Kuniyamuthur P.O., Coimbatore 641008, Tamil Nadu, India.
authors.forename: A P
authors.initials: AP
authors.lastname: Nagalakshmi
authors.affiliation: Department of Biostatistics, National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bangalore 560029, India.
authors.forename: P
authors.initials: P
authors.lastname: Marimuthu
authors.affiliation: Department of Biosciences, Jamia Milia Islamia, Jamia Nagar, New Delhi 110025, India.
authors.forename: Mamta
authors.initials: M
authors.lastname: Singh
authors.affiliation: Department of Biosciences, Jamia Milia Islamia, Jamia Nagar, New Delhi 110025, India.
authors.forename: Preetida J
authors.initials: PJ
authors.lastname: Bhetariya
authors.affiliation: Intertek Scientific & Regulatory Consultancy, 2233 Argentia Road, Suite 308, Mississauga, Ontario L5N 2X7, Canada.
authors.forename: Manki
authors.initials: M
authors.lastname: Ho
authors.affiliation: Intertek Scientific & Regulatory Consultancy, 2233 Argentia Road, Suite 308, Mississauga, Ontario L5N 2X7, Canada. Electronic address: ryan.simon@intertek.com.
authors.forename: Ryan R
authors.initials: RR
authors.lastname: Simon
mesh_terms: D000818:Animals; D002648:Child; D015362:Child Nutrition Disorders / Q000178:diet therapy*; D004032:Diet / Q000009:adverse effects; D019587:Dietary Supplements / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005396:Fish Products / Q000009:adverse effects*; D029941:Fish Proteins / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D011492:Protein Hydrolysates / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D029941:Fish Proteins; D011492:Protein Hydrolysates
keywords: Amizate®; Children; Fish protein hydrolysate; Growth; Malnutrition; Safety