• Title/Summary/Keyword: human clinical trial

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Fermented Laminaria japonica improves working memory and antioxidant defense mechanism in healthy adults: a randomized, double-blind, and placebo-controlled clinical study

  • Kim, Young-Sang;Reid, Storm N.S.;Ryu, Jeh-Kwang;Lee, Bae-Jin;Jeon, Byeong Hwan
    • Fisheries and Aquatic Sciences
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    • v.25 no.8
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    • pp.450-461
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    • 2022
  • A randomized, double-blind, and placebo-controlled clinical study was used to determine the cognitive functions related to working memory (WM) and antioxidant properties of fermented Laminaria japonica (FLJ) on healthy volunteers. Eighty participants were divided into a placebo group (n = 40) and FLJ group (n = 40) that received FLJ (1.5 g/day) for 6 weeks. Memory-related blood indices (brain-derived neurotrophic factor, BDNF; angiotensin-converting enzyme; human growth hormone, HGH; insulin-like growth factor-1, IGF-1) and antioxidant function-related indices (catalase, CAT; malondialdehyde, MDA; 8-oxo-2'-deoxyguanosine, 8-oxo-dG; thiobarbituric acid reactive substances, TBARS) were determined before and after the trial. In addition, standardized cognitive tests were conducted using the Cambridge Neuropsychological Test Automated Batteries. Furthermore, the Korean Wechsler Adult Intelligence Scale (K-WAIS)-IV, and the Korean version of the Montreal Cognitive Assessment (MoCA-K) were used to assess the pre and post intake changes on WM-related properties. According to the results, FLJ significantly increased the level of CAT, BDNF, HGH, and IGF-1. FLJ reduced the level of TBARS, MDA, and 8-oxo-dG in serum. Furthermore, FLJ improved physical activities related to cognitive functions such as K-WAIS-IV, MoCA-K, Paired Associates Learning, and Spatial Working Memory compared to the placebo group. Our results suggest that FLJ is a potential candidate to develop functional materials reflecting its capability to induce antioxidant mechanisms together with WM-related indices.

The Effects of Panax Ginseng Radix Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on the Heart Rate Variability (인삼약침과 산조인약침이 정상인의 심박 변이도에 미치는 영향)

  • Seol, Hyun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
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    • v.26 no.5
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    • pp.19-28
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    • 2009
  • Objectives : We tried to investigate the effects of Panax Ginseng Radix pharmacopuncture and Zizyphi Spinosi Semen pharmacopuncture on human body with the Heart Rate Variability (HRV) in adult man. As well as we tried to investigate how safe Panax Ginseng Radix and Zizyphi Spinosi Semen pharmacopuncture on the the human being. Methods : We investigated on 44 healthy volunteers consisted of 16 subjects in Panax Ginseng Radix pharmacopuncture group, 13 subjects in Zizyphi Spinosi Semen pharmacopuncture group and 15 subjects in Normal Saline. We ruled out subjects who wasn't stable by rest, with in the limit of normal heart beat(60-120cycle/min). Study form was a randomized, clinical trial. Each group was injected Panax Ginseng Radix pharmacopuncture, Zizyphi Spinosi Semen pharmacopuncture and Normal Saline $0.2m{\ell}$ at $GB_{21}$(Kyonjong). We measured HRV on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 13.0 for windows was used to analyze the data by the paired t-test(in the group) and Anova test(among the groups) were used to verify the result. Results : 1. After Panax Ginseng Radix pharmacopuncture injection, SDNN was significantly high, pNN50 was significantly low, Ln(TP) was significantly high, Ln(VLF) was significantly high, Ln(LF) was significantly high at 30 minutes. 2. After Zizyphi Spinosi Semen pharmacopuncture injection, Complexity was significantly low, Ln(VLF) was significantly high at 30 minutes. 3. HRV-index made a significant difference between the Zizyphi Spinosi Semen pharmacopuncture and normal saline at 5 minutes(p=0.02). 4. There wasn's any pain the injected region and whole body, rubefaction, uredo, nausea, vomiting, colic, headache, dizziness within 24 hours. Measured data and mean value of Mean-HRV was within normal range. Conclusions : The results suggested that and Panax Ginseng Radix pharmacopuncture in healthy adult man tended to activate the vagus nervous system within normal range.

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Inhibitory Effects of Silsosangami on the Platelet Aggregation

  • Kim Jong Soo;Kim Beob Jin;Kim Han Geu;Ahan Jong Chan;Lee Soo Kyung;Chung Tae Wook;Choi Dall Yeong;Kim Cheri Ho;Park Won Hwan
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.16 no.4
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    • pp.823-829
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    • 2002
  • The thrombosis importantly came to the front as the risk factor of these circulation system's disease. SilsoSanGami(SSG) was used for investigating the inhibitory effect on platelet-activating factor-induced platelet aggregation about drugs that used to improvement various symptoms created by the thrombosis in oriental medicine. In this study, the water-extracted SSG was investigated for its possible antithrombotic action on platelets. The antithrombotic activity of water-extracted SSG was deduced from its ability to suppress platelet aggregation, ATP-exocytosis, and the generation of prostaglandin E₂ and thromboxane A₂ by human platelets, stimulated with arachidonic acid. Water-extracted SSG dose-dependently suppressed the aggregation of human platelets, the release of endogenous ATP, and the formation of PGE₂ and TXB₂, both the latter usually detected to estimate the activity of COX and TXS, respectively. Since the IC/sub 50/ values necessary to inhibit COX (115 ㎍/㎖ SSG) and TXS(74 ㎍/㎖ SSG) were in the same range, inhibition of COX is suggested to be the primary target of water-extracted SSG, thus suppressing the formation of PGE₂ which is metabolized by TXS to TXA₂. We considerated that SSG has practical applicational value of clinical trial in the thrombosis caused by platelet aggregation.

Application of Human Dermal Fibroblast and Keratinocyte on Allogenic Dermis(AlloDerm®) (동종진피에 사람진피 섬유모세포와 각질세포를 적용한 인공피부의 실험적 제작)

  • Oh, Jung Chul;Lim, Yeung Kook;Jeong, Jae Ho
    • Archives of Plastic Surgery
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    • v.33 no.5
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    • pp.601-605
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    • 2006
  • Purpose: Large skin defect by various causes, should be covered by autologous skin graft. But, the donor site of autologous skin graft is limited and leaves permanent donor scar and contracture. There have been our trial to engineer artificial skin using allogenic dermis (AlloDerm) with basement membrane. Methods: Dermal and epidermal layer were separated by immersing in dipase solution for 30 minutes, and the separated layers were treated with 0.05% trypsin for 10 minutes. And then each layer was cultivated to fibroblasts and keratinocytes on a culture medium. Fibroblasts were first penetrated into basement membrane of allogenic dermis facing down, then allogenic dermis was flipped over to face up and keratinocytes were transplanted to allogenic dermis. Results: Observing artificial skin fabricated in vitro, we found following: 1) The artificial skin opened in air for 5 days formed epidermal layer. In dermal layer, fibroblast was distributed evenly among all. 2) The artificial skin opened in air for 30 days formed thicker and thicker, and it formed basement membrane, spinous and granular layers. PAS stain to confirm existence of basement membrane showed positive reaction. 3) Cytokeratin 10 stain to confirm the formation of epidermal layer showed positive reaction. 4) The formation of thick keratin, lamellar body and desmosome similar to human skin were observed in result of an electron micrograph. Conclusion: As a result of research, the structure seen in normal skin such as rete ridge, is found in reproduced artificial skin. This type of artificial skin can be used as a useful model for investigating skin disease and for clinical application also.

Antitumor effects of recombinant human interferon α-2a and hydroxyurea against chronic myelogenous leukemia (만성 골수성 백혈병에 대한 유전자 재조합 인터페론 α-2a와 hydroxyurea의 항암효과)

  • Kim, Chang-hwan;Lee, Beom-jun;Park, Jong-hwan;Park, Jae-hak
    • Korean Journal of Veterinary Research
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    • v.40 no.1
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    • pp.166-172
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    • 2000
  • Prior to a clinical trial, the in vitro and in vivo antitumor effects of a new recombinant human interferon ${\alpha}-2a$ (rHu/IFN ${\alpha}-2a$) with/without hydroxyurea (HU) were investigated using chronic myelogenous leukemia (CML)-derived cell lines (K562 and KU812F) and BALB/c nude. mice transplanted with KU812F cells. The rHu/IFN ${\alpha}-2a$ ($10^4-10^6IU/ml$) strongly inhibited proliferation of both cell lines and the combined treatments with HU ($10{\mu}g/ml$) were more effective. In nude mice transplanted with KU812F cells. rHu/IFN ${\alpha}-2a(1{\times}10^6IU$) inhibited tumor growth by 42-65% at 15-21 days post-transplantation (DPT). The combined treatment of rHu/IFN ${\alpha}-2a (5{\times}10^5IU$) with HU (0.25mg/g b.w.) inhibited the tumor growth by 48-67% at 12-21 DPT. In addition, the treatment of rHu/IFN ${\alpha}-2a$ ($5{\times}10^6IU\;or\;1{\times}10^7IU$) rejected tumor transplantation by 40%. These results suggest that the new rHU/IFN ${\alpha}-2a$ alone or with HU is effective on CML cell lines.

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Effect of Cimetidine and Phenobarbital on Metabolite Kinetics of Omeprazole in Rats

  • Park Eun-Ja;Cho Hea-Young;Lee Yong-Bok
    • Archives of Pharmacal Research
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    • v.28 no.10
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    • pp.1196-1202
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    • 2005
  • Omeprazole (OMP) is a proton pump inhibitor used as an oral treatment for acid-related gastrointestinal disorders. In the liver, it is primarily metabolized by cytochrome P-450 (CYP450) isoenzymes such as CYP2C19 and CYP3A4. 5-Hyroxyomeprazole (5-OHOMP) and omeprazole sulfone (OMP-SFN) are the two major metabolites of OMP in human. Cimetidine (CMT) inhibits the breakdown of drugs metabolized by CYP450 and reduces, the clearance of coad-ministered drug resulted from both the CMT binding to CYP450 and the decreased hepatic blood flow due to CMT. Phenobarbital (PB) induces drug metabolism in laboratory animals and human. PB induction mainly involves mammalian CYP forms in gene families 2B and 3A. PB has been widely used as a prototype inducer for biochemical investigations of drug metabolism and the enzymes catalyzing this metabolism, as well as for genetic, pharmacological, and toxicological investigations. In order to investigate the influence of CMT and PB on the metabolite kinetics of OMP, we intravenously administered OMP (30 mg/kg) to rats intraperitoneally pretreated with normal saline (5 mL/kg), CMT (100 mg/kg) or PB (75 mg/kg) once a day for four days, and compared the pharmacokinetic parameters of OMP. The systemic clearance ($CL_{t}$) of OMP was significantly (p<0.05) decreased in CMT-pretreated rats and significantly (p<0.05) increased in PB-pretreated rats. These results indicate that CMT inhibits the OMP metabolism due to both decreased hepatic blood flow and inhibited enzyme activity of CYP2C19 and 3A4 and that PB increases the OMP metabolism due to stimulation of the liver blood flow and/or bile flow, due not to induction of the enzyme activity of CYP3A4.

The effects of daily intake timing of almond on the body composition and blood lipid profile of healthy adults

  • Liu, Yanan;Hwang, Hyo-Jeong;Ryu, Hyesook;Lee, You-Suk;Kim, Hyun-Sook;Park, Hyunjin
    • Nutrition Research and Practice
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    • v.11 no.6
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    • pp.479-486
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    • 2017
  • BACKGROUND/OBJECTIVES: Timing of almond intake during a day may result differently in the perspectives of body composition and changes of lipid profile. The current study was conducted to compare the effects of daily almond intake as a preload versus as a snack on body composition, blood lipid profile, and oxidative and inflammation indicators among young Korean adults aged 20-39 years old. SUBJECTS/METHODS: Participants were randomly assigned to one of three groups: a pre-meal almond group (PM), a snack almond group (SN) in which participants were instructed to consume 56 g of almonds either as a preload before meals or as a snack between meals, respectively, and a control group (CL) in which participants were provided high-carbohydrate iso-caloric control food. Measurements were performed at baseline, weeks 8 and 16. RESULTS: A total of 169 (M 77 / F 92) out of the 227 participants completed the study between June 2014 and June 2015 (n = 58 for PM; 55 for SN; and 56 for CL). A significant decrease in body fat mass was observed in the PM group at both weeks 8 and 16 compared with the CL. There were significant intervention effects on changes of body fat mass (P = 0.025), body fat percentages (P = 0.019), and visceral fat levels (P < 0.001). Consuming almonds as a daily snack reduced the levels of total cholesterol (P = 0.043) and low-density lipoprotein (LDL) cholesterol (P = 0.011) without changing high-density lipoprotein (HDL) cholesterol compared with the CL. CONCLUSION: Almond consumption as a preload modified body fat percentages, whereas snacking on almonds between meals improved blood lipid profiles. This trial was registered at ClinicalTrials.gov as NCT03014531.

Extracellular Vesicles from Korean Codium fragile and Sargassum fusiforme Negatively Regulate Melanin Synthesis

  • Jang, Bohee;Chung, Heesung;Jung, Hyejung;Song, Hyun-Kuk;Park, Eunhye;Choi, Hack Sun;Jung, Kyuhyun;Choe, Han;Yang, Sanghwa;Oh, Eok-Soo
    • Molecules and Cells
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    • v.44 no.10
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    • pp.736-745
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    • 2021
  • Although various marine ingredients have been exploited for the development of cosmetic products, no previous study has examined the potential of seaweed extracellular vesicles (EV) in such applications. Our results revealed that EV from Codium fragile and Sargassum fusiforme effectively decreased α-MSH-mediated melanin synthesis in MNT-1 human melanoma cells, associated with downregulation of MITF (microphthalmia-associated transcription factor), tyrosinase and TRP1 (tyrosinase-related proteins 1). The most effective inhibitory concentrations of EV were 250 ㎍/ml for S. fusiforme and 25 ㎍/ml for C. fragile, without affecting the viability of MNT-1 cells. Both EV reduced melanin synthesis in the epidermal basal layer of a three-dimensional model of human epidermis. Moreover, the application of the prototype cream containing C. fragile EV (final 5 ㎍/ml) yielded 1.31% improvement in skin brightness in a clinical trial. Together, these results suggest that EV from C. fragile and S. fusiforme reduce melanin synthesis and may be potential therapeutic and/or supplementary whitening agents.

Growth and clinical efficacy of fortified human milk and premature formula on very low birth weight infants (극소 저체중출생아에서 강화된 모유와 미숙아 전용분유가 성장 및 임상에 미치는 효과)

  • Chueh, Heewon;Kim, Myo Jing;Lee, Young-A;Jung, Jin-A
    • Clinical and Experimental Pediatrics
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    • v.51 no.7
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    • pp.704-712
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    • 2008
  • Purpose : A prospective, controlled trial was conducted to evaluate growth, efficacy, safety and nutritional status for very low birth weight infants fed with human milk fortified with Maeil human milk fortifier (Maeil $HMF^{(R)}$; Maeil Dairies Co., Ltd.). Methods : We enrolled 45 premature infants with a birth weight <1,500 g and gestational age <33 weeks, who were born at Dong-A University Hospital from October, 2006 through December, 2007. They were divided into 2 groups: infants in one group were fed with human milk fortified with $HMF^{(R)}$, and the second were fed with preterm formula. Growth, biochemical indices, feeding tolerance, and other adverse events in each group were assessed serially and compared relatively. Follow-up data were also collected after discharge at 1, 3, and 6 months corrected age. Results : Characteristics of the 2 groups including average gestational age, birth weight, sex, respiratory distress syndrome, patent ductus arteriosus, and other adverse events (sepsis, retinopathy of prematurity, and intraventricular hemorrhage) showed no significant difference. Average feeding start day ($8.00{\pm}3.27d$ vs. $8.86{\pm}5.37d$) (P=0.99) and the number of days required to reach full feeding after start feeding ($41.78{\pm}20.47d$ vs $36.86{\pm}20.63d$) (P=0.55) were not significantly different in the group fed human milk fortified with $HMF^{(R)}$ when compared with the group that was fed preterm formula. The duration of total parenteral nutrition and the incidence of feeding intolerance also showed no differences between the 2 groups. Although infants fed with human milk fortified with $HMF^{(R)}$ showed faster weight gain than those fed with preterm formula at the end stage of the admission period, other growth indices of the two groups showed no significant difference. No significant correlations were found between the 2 groups with regard to weight gain velocity, height gain velocity, head circumference velocity, and post-discharge follow up growth indices. Conclusion : Premature infants fed human milk fortified with $HMF^{(R)}$ showed no significant difference compared with those fed preterm formula in growth, biochemical indices, and adverse events. Using human milk fortifier can be an alternative choice for very low birth weight infants, who need high levels nutritional support even after discharge from NICU.

Thinning and drilling laser-assisted hatching in thawed embryo transfer: A randomized controlled trial

  • Le, Minh Tam;Nguyen, Thi Tam An;Nguyen, Thi Thai Thanh;Nguyen, Van Trung;Le, Dinh Duong;Nguyen, Vu Quoc Huy;Cao, Ngoc Thanh;Aints, Alar;Salumets, Andres
    • Clinical and Experimental Reproductive Medicine
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    • v.45 no.3
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    • pp.129-134
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    • 2018
  • Objective: In frozen and thawed embryos, the zona pellucida (ZP) can be damaged due to hardening. Laser-assisted hatching (LAH) of embryos can increase the pregnancy rate. This study compared thinning and drilling of the ZP before frozen embryo transfer (FET). Methods: Patients were randomly allocated into two groups for LAH using thinning or drilling on day 2 after thawing. Twenty-five percent of the ZP circumference and 50% of the ZP thickness was removed in the thinning group, and a hole $40{\mu}m$ in diameter was made in the drilling group. Results: A total of 171 in vitro fertilization/intracytoplasmic sperm injection FET cycles, including 85 cycles with drilling LAH and 86 cycles with thinning LAH, were carried out. The thinning group had a similar ${\beta}$-human chorionic gonadotropin-positive rate (38.4% vs. 29.4%), implantation rate (16.5% vs. 14.4%), clinical pregnancy rate (36.0% vs. 25.9%), miscarriage rate (5.8% vs. 2.4%), ongoing pregnancy rate (30.2% vs. 23.5%), and multiple pregnancy rate (7.0% vs. 10.6%) to the drilling LAH group. There were no significant differences in pregnancy outcomes between subgroups defined based on age (older or younger than 35 years) or ZP thickness (greater or less than $17{\mu}m$) according to the LAH method. Conclusion: The present study demonstrated that partial ZP thinning or drilling resulted in similar outcomes in implantation and pregnancy rates using thawed embryos, irrespective of women's age or ZP thickness.