Title
Safety evaluation of an IPP tripeptide-containing milk protein hydrolysate
Author
Ponstein-Simarro Doorten, A.Y.
van de Wiel, J.A.G.
Jonker, D.
TNO Kwaliteit van Leven
Publication year
2009
Abstract
Tensguard™ is a milk protein hydrolysate containing the lactotripeptide IPP. It is derived from cow's milk, which is present in the human diet and has a safe history of consumption. The final Tensguard™ product, a supplement or a functional food ingredient, is intended for use by people who want to follow a healthy diet and lifestyle in order to manage their blood pressure. The safety-in-use of commercial lactotripeptide-containing products has been confirmed in several in vitro and in vivo toxicity studies and in studies with humans. To support the safety, Tensguard™ was examined in three in vitro genotoxicity tests (bacterial reverse mutation test, mammalian cell gene mutation test and mammalian chromosomal aberration test) and in a 90-day repeated-dose oral toxicity study in rats. The genotoxicity tests confirm that Tensguard™ is not mutagenic or clastogenic. The NOAEL from the 90-day study was at the highest dose tested, i.e. 4% in the diet. The NOAEL is equivalent to an overall mean intake of 2 g Tensguard™/kg body weight/day and corresponds to 40 mg IPP/kg body weight/day. This is 141-fold higher than the maximal anticipated intake. In conclusion, Tensguard™ is safe under the conditions of intended use. © 2008 Elsevier Ltd. All rights reserved.
Subject
Nutrition
toxicology and applied pharmacology
blood pressure
body weight
CH
FM
generally recognized as safe
glycomacropeptide
GMP
GRAS
IPP
isoleucine-proline-proline
lactotripeptide
margin of safety
milk protein hydrolysate
MOS
no-observed-adverse-effect level
NOAEL
safety evaluation
skim milk fermented with Lactobacillus helveticus
valine-valine-proline
VPP
lactotripeptide
milk protein
protein hydrolysate
tripeptide derivative
unclassified drug
animal cell
animal experiment
animal tissue
article
blood pressure regulation
chromosome aberration
controlled study
cow
diet supplementation
female
food intake
food safety
gene mutation
genotoxicity
good laboratory practice
in vitro study
in vivo study
lifestyle
liver homogenate
male
mammal cell
mouse
mutagenic activity
nonhuman
protein content
protein intake
rat
animals
cattle
cell line
chromosome aberrations
escherichia coli
female
male
mice
milk proteins
mutagenicity tests
oligopeptides
rats
wistar rats
salmonella typhimurium
specific pathogen-free organisms
aspergillus oryzae
bacteria (microorganisms)
lactobacillus helveticus
mammalia
rattus
To reference this document use:
http://resolver.tudelft.nl/uuid:6fbcf588-4376-41fd-ad4d-a62153b60534
DOI
https://doi.org/10.1016/j.fct.2008.10.001
TNO identifier
241320
ISSN
0278-6915
Source
Food and Chemical Toxicology, 47 (1), 55-61
Document type
article