• Journal of the Korean Society of Food Science and Nutrition
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• v.39 no.7
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• pp.1038-1048
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• 2010

The purpose of this study was to investigate some heavy metals (Pb, Cd, Cr, Cu, Hg) in 52 commercial herbal pills used as general processed food, to identify weekly heavy metal intakes from herbal pills and to evaluate their potential health risks. The samples were digested with a microwave and determinations of heavy metal residues were carried out by inductively coupled plasma mass spectrometry (ICP-MS) and mercury analyzer. The mean values of heavy metal contents for herbal pills used as general processed food were Pb 0.421 (0.032~1.630), Cd 0.157 (0.011~0.515), Cr 1.033 (0.112~9.933), Cu 6.923 (1.333~16.755), Hg 0.010 (0.001~0.088) mg/kg. Lead contents of herba and cadmium of algae, herba were high (ANOVA-test, p<0.05). Levels of cadmium concentrations exceeding WHO reference values (0.3 mg/kg) were observed in 10 samples (4 species). The significant correlation was observed between Pb and Cd (r=0.633, p<0.01). The weekly intakes of Pb, Cd, Cr, Cu, Hg from herbal pills were 1.112 (0.072~5.088), 1.614 (0.029~9.257), 3.000 (0.252~23.690), 0.182 (0.008~1.235), 0.220 (0.000~0.420)%, respectively, as compared with the Provisional Tolerable Weekly Intake (PTWI) established by Joint FAO/WHO Expert Committee for food safety evaluation. Our data suggest regulations limiting heavy metals in herbal pills used as general processed food.

• Journal of Nutrition and Health
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• v.52 no.2
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• pp.227-241
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• 2019

Purpose: This study examined the relationship between caffeine intake and metabolic syndrome in Korean adults using the 2013 ~ 2016 Korea National Health and Nutrition Examination Survey data (KNHANES). Methods: The caffeine database (DB) developed by Food and Drug Safety Assessment Agency in 2014 was used to estimate the caffeine consumption. The food and beverage consumption of the 24 hr recall data of 2013 ~ 2016 KNHANES were matched to items in the caffeine DB and the daily caffeine intakes of the individuals were calculated. The sample was limited to non-pregnant healthy adults aged 19 years and older, who were not taking any medication for disease treatment. Results: The average daily caffeine intake was 41.97 mg, and the daily intake of caffeine of 97% of the participants was from coffee, teas, soft drinks, and other beverages. Multivariate analysis showed that the caffeine intake did not affect metabolic syndrome, hypertension, low HDL-cholesterol, and abdominal obesity. Diabetes and hypertriglyceridemia, however, were 0.76 (95% CI: 0.63 ~ 0.93), and 0.87 (95% CI: 0.77 ~ 0.98) in third quintile (Q3), and 0.66 (95% CI: 0.53 ~ 0.82) and 0.83 (95% CI: 0.73 ~ 0.94) in fourth quintile (Q4) compared to Q1, respectively. Therefore, caffeine intake of 3.66 ~ 45.81 mg per day is related to a lower risk of diabetes and hypertriglyceridemia. Conclusion: The study showed that adequate caffeine intake (approximately 45 mg) was associated with a lower prevalence of diabetes and hypertriglyceridemia. Therefore, it can be used as a guideline for the adequate level of caffeine intake for maintaining health.

• The Korean Journal of Pesticide Science
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• v.14 no.1
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• pp.1-9
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• 2010

In order to survey residual characteristics of pesticides in the agricultural products selling at markets and to assess their safety, a total of 120 agricultural products were collected from the wholesale and traditional markets in Cheongju and analyzed the pesticide residues in them by multiresidue analysis method using GLC, HPLC and GC-MSD. Three pesticides, procymidone, penconazole, and tetraconazole, were detected from 4 samples such as onion, leek, tomato, and green pepper. Fungicide penconazole was detected from the onion collected from wholesale market. Fungicide procymidone was detected from leek and tomato and fungicide tetraconazole was detected from green pepper. Pesticide residues were detected from 3.3% of the total samples. The estimated daily intakes (EDIs) of the pesticides detected were less than 0.1% of their acceptable daily intakes (ADIs), representing that residue levels of the pesticides detected were evaluated as safe.

• Journal of Ginseng Research
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• v.45 no.5
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• pp.546-554
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• 2021

Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;

• Journal of the Korean Society of Marine Environment & Safety
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• v.25 no.1
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• pp.81-88
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• 2019

In order to understand the effects of the main components of antifoaming agents on the marine benthic ecosystem when silicone-based antifoaming agents are discharged into marine environments, eco-toxicity testing was performed on silicone and alcohol-based antifoaming agent by using benthic amphipod (Monocorophium acherusicum) and luminescent bacteria (Vibrio fischeri). The toxic effects of Polydimethylsiloxane (PDMS) as a main component of silicone-based antifoaming agents on aquatic organisms were also researched. In the results of the eco-toxicity test, luminescent bacteria showed a maximum of 9 times more toxic effects than benthic amphipod for alcohol-based antifoaming agents, and silicone-based antifoaming agents showed a maximum of 400 times more toxic effects than alcohol-based. The $LC_{50}$ and $EC_{50}$ values of PDMS ranged from 10 to $44,500{\mu}g/L$ in phytoplankton, invertebrate, and fish. In the results of applying PBT (P: persistency, B: bioaccumulation, T: toxicity) characteristics as an index showing the qualitative characteristics of PDMS, persistency (P) and bioaccumulation (B) were confirmed. Thus, when PDMS is discharged to marine environments, it could accumulate in the upper trophic level through bioaccumulation and the food chain, which could have negative effects on benthic organisms. The results of this study may be used for objective and scientific risk assessment, considering the major components of antifoaming agents when investigating the effects of various discharged antifoaming agents in marine ecosystem.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• Culinary science and hospitality research
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• v.15 no.4
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• pp.1-8
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• 2009

The aim of this study is to investigate the microbial contamination assessment of raw Jinmichae to cook and to establish its control. Three kinds of Korean Jinmichae products(K1, K2, K3) and three kinds of imported Jinmichae products(Chile: F1, Peru: F2, Mexico: F3) were collected from markets and department stores in Seoul and Gyeonggi-do. The results were as follows; Aerobic mesophilic bacteria in raw Jinmichae(F2) was detected $7.20{\times}10^7$ CFU/g, which exceeded the acceptable standard level, $1.0{\times}10^6$ CFU/g. The rest of raw groups fell up to $1.0{\times}10^3{\sim}1.0{\times}10^4$ CFU/g. Aerobic mesophilic bacteria were detected in blanched and fried Jinmichae groups. Boiled Jinmichae group did not exceed the acceptable standard level of $1.0{\times}10^6$ CFU/g. However, all the fried groups exceeded the level. E. coli were detected in raw Jinmichae but it was able to be controlled by blanching. Unlike this, E. coli was not completely controlled by roasting for 20 seconds relative to 40, 60 seconds. S. aureus were effectively controlled by boiling, however, it was not controlled by roasting. After roasting Jinmichae for 60 seconds, S. aureus were detected in the half of all groups. In this study, Jinmichae were found to be favorable one of side dishes in school meal service. Jinmichae can be contaminated by microbial pathogens such as S. aureus, E. coli, etc. Therefore, further studies are needed to monitor microbial pathogens and to provide their control.

• Journal of Korean Medicine Rehabilitation
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• v.25 no.3
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• pp.1-9
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• 2015

Objectives To evaluate Shinbaro Pharmacopuncture safety through analysis of potential single-dose intramuscular toxicity of Sinbaro Pharmacopucture in SD rats and Beagle dogs. Methods Single-dose intramuscular toxicity of Shinbaro Pharmacopuncture was assessed in accordance with Korea Food and Drug Administration Guidelines for toxicity testing of Medicinal Products. The SD rats were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 0, 4.6, 9.2, and 18.5 mg/kg, respectively. The Beagle dogs were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 2.3, and 4.6 mg/kg, respectively, and after 3 days, the procedure was repeated a second time at doses of 0.6, and 1.2 mg/kg, respectively, for toxicity testing. Mortality, change in body weight, and necropsy findings were examined for the study period. Results There were no mortalities, general symptoms, or body weight changes in the SD rats. While pyelectasis of the left kidney was observed in a male rat in the 4.6 mg/kg administration group, natural occurrence is common, and does not appear to be related with the test substance. No mortalities were observed in the Beagle dogs. In assessment of general symptoms, a female dog in the 9.2 mg/kg group displayed body weight decrease due to leftover food, but the change in body weight was within the normal range seen at 6~7 months, and the necropsy findings were not significant. The toxicity of the test substance appears to be minimal. Conclusions The results suggest that the lethal dose 50 ($LD_{50}$) and approximate lethaldose (ALD) value in single intramuscular administration of Shinbaro Pharmacopuncture in SD rats and Beagle dogs are higher than 18.5 mg/kg.

• The Korean Journal of Pesticide Science
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• v.15 no.4
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• pp.507-528
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• 2011

Agricultural workers who mix/loads and spray pesticide in fields expose to pesticide through dermal and inhalation routes. In such situation, exposed amount should be measured quantitatively for reasonable risk assessment. Patch, gloves, socks and mask will be good materials for monitoring for dermal exposure while personal air monitor equipped with solid adsorbent and air pump will be a tool for inhalation exposure. For extrapolation of absorbed amount in dermal exposure matrices and of trapped amount in solid sorbent to total deraml or inhalation exposure, Korean standard body surface area and respiration rate were proposed in substitution of EPA data. Important exposure factors such as clothing and skin penetration ratio of dermal and inhalation exposure were suggested based on Spraying time for exposure monitoring must be long enough that the amount of pesticide to get absorbed/trapped in exposure matrices results in reasonable analytical value. In domestic case for the both of speed sprayer and power spray machine, spraying time of 20~40 minutes (0.1~0.2 ha) will be reasonable per single replicate before extrapolating to 4 hours a day with triplicates experiment.