To ensure the safety of Frutarom`s SoyLife products several tests were performed. No Observed Adverse Effect Level with respect to growth, behaviour, food & water intake, and organ weights and structure were reported. It is concluded that SoyLife is not mutagenic in the Salmonella typhimurium reverse mutation assay (a biological assay to assess the mutagenic potential of chemical compounds). A positive test indicates that the chemical might act as a carcinogen and the Escherichia coli reverse mutation assay at high concentrations. Further tests did lead to the conclusion that SoyLife is not clastogenic (breaking of Chromosomes) in human lymphocytes and is not mutagenic in the micronucleus test (toxicological screening for potential genotoxic compounds). Additional safety of SoyLife guaranteed by many human clinical trials and investigations were no significant side effects were observed by the consumption or use of daidzein rich soy products.
Especially the outcome of the OPUS study, a multicenter, randomized, double-blind, placebocontrolled 24-month trial with supplementation of 80 or 120 mg aglycone equivalent soy hypocotyl isoflavones plus calcium and vitamin D on the health on 403 postmenopausal women is supporting that fact. Maskarinec at al did conclude in 2009 that isoflavone supplements containing of SoyLife did not modify breast density in postmenopausal women and that breast density decrease was normal throughout the course of the OPUS study. These results show that a long-term intake of soy germ isoflavones in high concentrations do not have a negative influence on breast health. In addition Steinberg et al did conclude in 2010 that daily supplementation of daidzein rich soy products can be regarded as safe in healthy menopausal women. In general research of the last year did show that consumption of soy products and/or supplements can be considered as safe. Also in the clinical trials where equol was supplemented no significant adverse effects were observed. Finally no significant side/adverse effects were reported by supplementation of daidzein rich products to male persons.
By Notox, The Netherlands, 2000 and 2001.
Maskarinec et al J. Nutr. 139 (2009), 981-986.
Francene M Steinberg, Am J Clin Nutr. 2011 Feb;93(2):356-67.