• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

• Journal of the Korean Society of Food Science and Nutrition
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• v.43 no.11
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• pp.1658-1664
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• 2014

Sprout vegetables containing various types of polyphenols and flavonoids, are known to have anti-inflammatory, antioxidant, cholesterol-lowering, and anti-obesity activities. However, there have been few reports on the anti-diabetic efficacy of sprout vegetables. Here, we investigated the anti-diabetic effects of sprout extract obtained from buckwheat, beet, rape, broccoli, kohlrabi, red young radish, and dachai, in high fat diet (HFD) and streptozotocin (STZ)-induced type II diabetes mellitus mice. The mice were fed a HFD (60% calories as fat) for 8 weeks prior to intraperitoneal injection with STZ (75 mg/kg). The diabetic mice were divided into four groups: standard diet (STD, 10% calories fat), HFD, HFD with sprout extract (SPE) and HFD with metformin (MET). After 4 weeks, body weight gain was much lower in both SPE and MET groups than in HFD group. In contrast, there was no difference experiment groups regarding food intake ratio. The level of fasting blood glucose was significantly lower in the SPE and MET groups compared to the HFD group. Oral glucose tolerance and insulin tolerance in the SPE and MET groups were significantly ameliorated in comparison to the HFD group. The concentrations of serum total cholesterol, triglycerides, and LDL cholesterol in the SPE and MET groups were remarkably reduced in comparison to the HFD group, and HDL cholesterol concentration was higher in the SPE and MET groups than in the HFD group. Glutamate oxaloacetate transaminase and glutamate pyruvate transaminase levels were between SPE and HFD groups. The serum insulin and leptin concentrations were significantly reduced in both the SPE and MET groups compared to the HFD group. Therefore, these results indicate that sprout extract could improve insulin resistance and attenuate blood glucose level in HFD/STZ-induced type II diabetes mellitus mice. We conclude that this study may provide positive insights into sprout extract as a functional food ingredient for treatment of type II diabetes mellitus.

• Journal of the Korean Society of Food Science and Nutrition
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• v.46 no.4
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• pp.490-500
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• 2017

This study was performed to evaluate repeated dose oral toxicity upon administration of the test substance 1,2-benzisothiazolin-3-one for 90 days and to determine NOAEL (no observed adverse effect level) and target organs in Sprague-Dawley rats. Single, 2-week repeated, and 13-week repeated oral dose toxicity studies were conducted in Sprague-Dawley rats. The dose levels of groups were 1,250, 2,500, and 5,000 mg/kg/d. All dose groups were compared with the vehicle control group. The animals were observed for clinical signs and weekly body weight. Urinalysis, hematology, and serum biochemistry analyses were conducted. Subsequently, animals were sacrificed and subjected to histopathological examination. For the result, NOAEL of ethanol extract from unripe fruit of bitter melon had an optimal dose of 5,000 mg/kg/d and acceptable daily intake up to 3,000 mg/man. There was no target organ detected. Therefore, bitter melon, which contains a variety of bioactive substances, could be widely used as a health functional food ingredient.

• The Journal of the Convergence on Culture Technology
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• v.4 no.3
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• pp.197-207
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• 2018

The radish skin and radish greens (mucheong) are an edible part of the radish. But they are removed before eating the radish and used as a byproduct or an animal feed material because of their tough and rough texture. This study was conducted to investigate the effect of supercritical heat-treated radish-extract on UV-induced Hos: HRM-2 wrinkled mouse animal model on anti-aging wrinkles. Supercritical heat-treated radish-extract was applied on the back of seven-weeks old HRM-2 mice. The effect of HRE on skin thickness, elasticity and wrinkle formation of the mice was observed by using UVB lamp to induce melanogenesis and wrinkle formation. As the result, increased depth of wrinkles was observed in the negative control group in comparison to the normal group. In contrast, decreased depth of wrinkles was observed in the radish-extract-free group compared to the negative control group. In the study of the effect of radish-extract on wrinkle-formation related gene expression and protein what protein expression, MMP-2 and MMP-2 gene expression significantly increased in the negative control group compared to the normal group. The gene expression reduced independence to the mass of radish-extract treated. Similar to quantitative results of mRNA expression, the expression of MMP-2 protein increased as a result of UVB-irradiation. The MMP-2 expression was inhibited in dependence to the mass of radish-extract treated. In conclusion, the supercritical heat-treated radish-extract has an effect on improving skin wrinkles not only when it is applied to the skin but also when orally ingested. Thus, it can be effectively used as a composition to health functional products. Thereafter, we can also conclude that radish, a food that does not show any side-effects even upon long-term intake, can reduce wrinkle formation as well as improve skin elasticity when taken regularly for a long period.