• Title/Summary/Keyword: randomized controlled double blind study

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The influence of obesity on the effects of spirulina supplementation in the human metabolic response of Korean elderly

  • Park, Hee-Jung;Lee, Hyun-Sook
    • Nutrition Research and Practice
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    • v.10 no.4
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    • pp.418-423
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    • 2016
  • BACKGROUND/OBJECTIVES: Spirulina, a blue-green alga, is widely produced and commercialized as a dietary supplement with bio- and immune-modulatory functions. We have previously shown that spirulina had favorable effects on lipid profiles, immune functions, and antioxidant capacity in healthy Korean elderly. Despite favorable effect of spirulina supplementation, some sub-populations have shown a poor response to supplementation. Obesity is a factor related to poor-response. Therefore, the purpose of this study was to determine the immuno-modulation, antioxidant capacity, and lipid-lowering effect of spirulina in obese and non-obese Korean elderly. SUBJECTS/METHODS: The subjects were 78 elderly aged 60-87 years. In a randomized double blind, placebo-controlled study, subjects were fed either placebo or spirulina daily, at 8 g for 12 weeks. Subjects were divided into the non-obese group and the obese group based on body mass index (BMI) criteria for Asians suggested by the International Obesity Task Force: $BMI<25kg/m^2$ (non-obese) and $BMI{\geq}25kg/m^2$ (obese). RESULTS: In the non-obese group, spirulina supplementation showed a significant lowering effect on plasma concentration of total cholesterol and LDL-cholesterol, a significant increase in interleukin (IL)-2 concentration (P < 0.01) and a significant increment (P < 0.05) in IL-2/IL-6 ratio, and a significant increase in total antioxidant status level and a significant decrease in thiobarbituric acid reactive substances level. However, these effects were not observed in the obese group. CONCLUSION: These results demonstrated that blood lipid lowering and immune and antioxidant improving response for spirulina supplement was affected by obesity in Korean elderly.

Effects of Sweet Bee Venom and Bee Venom on the Heart Rate Variability (Sweet Bee Venom과 Bee Venom이 심박변이도(HRV)에 미치는 영향)

  • Yook, Tae-Han;Yu, Jung-Suk;Jung, Han-Sung
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.41-54
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    • 2008
  • Objective : In this study, we investigated the effects of Sweet Bee Venom(SBV) and Bee Venom(BV) at a acupoint, HT7(Shinmun) on the Heart Rate Variability(HRV) in the healthy man. And we tried to observe how Sweet Bee Venom and Bee Venom affects on the balance of the autonomic nervous system. Methods : We investigated on 22 heathy volunteers consisted of 10 subjects in SBV group and 12 subjects in BV group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 22 subjects of each group were injected SBV and BV at HT7(Shinmun). And we measured HRV by QECG-3:LXC3203 (LAXTHA Inc. Korea) on 7 times : before and after injection per 5minutes during 30minutes. Results : 1. After SBV injection, Mean-RR was significantly high from 0 to 10 minutes, Mean-HRV was significantly low from to 10 minutes, SDNN was significantly high after 25minutes, Complexity was significantly high from 5 to 10 minutes and RMSSD was significantly high from 5 to 10minutes. 2. Complexity of SBV Group significantly decreased from 20 to 25minutes, RMSSD of SBV Group significantly increased from 10 to 15minute and from $20{\sim}25$minutes, SDSD of SBV Group significantly increased from 10 to 15 minute and from $20{\sim}25$minutes compared with that of BV group. 3. After SBV injection, Ln(VLF) was significantly from 25 to 30minutes. Conclusions : The results suggest that SBV in heathy adult man tend to activate the autonomic nervous system compared to BV within normal range.

Effects of Low-Dose Aspirin Therapy on Thermoregulation in Firefighters

  • McEntire, Serina J.;Reis, Steven E.;Suman, Oscar E.;Hostler, David
    • Safety and Health at Work
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    • v.6 no.3
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    • pp.256-262
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    • 2015
  • Background: Heart attack is the most common cause of line-of-duty death in the fire service. Daily aspirin therapy is a preventative measure used to reduce the morbidity of heart attacks but may decrease the ability to dissipate heat by reducing skin blood flow. Methods: In this double-blind, placebo-controlled, crossover study, firefighters were randomized to receive 14 days of therapy (81-mg aspirin or placebo) before performing treadmill exercise in thermal-protective clothing in a hot room [$38.8{\pm}2.1^{\circ}C$, $24.9{\pm}9.1%$ relative humidity (RH)]. Three weeks without therapy was provided before crossing to the other arm. Firefighters completed a baseline skin blood-flow assessment via laser Doppler flowmetry; skin was heated to $44^{\circ}C$ to achieve maximal cutaneous vasodilation. Skin blood flow was measured before and after exercise in a hot room, and at 0 minutes, 10 minutes, 20 minutes, and 30 minutes of recovery under temperature conditions ($25.3{\pm}1.2^{\circ}C$, $40.3{\pm}13.7%\;RH$). Platelet clotting time was assessed before drug administration, and before and after exercise. Results: Fifteen firefighters completed the study. Aspirin increased clotting time before and after exercise compared with placebo (p = 0.003). There were no differences in absolute skin blood flow between groups (p = 0.35). Following exercise, cutaneous vascular conductance (CVC) was $85{\pm}42%$ of maximum in the aspirin and $76{\pm}37%$ in the placebo groups. The percentage of maximal CVC did not differ by treatment before or after recovery. Neither maximal core body temperature nor heart rate responses to exercise differed between trials. Conclusion: There were no differences in skin blood flow during uncompensable heat stress following exercise after aspirin or placebo therapy.

The Effects of 30-Minutes of Pre-Warming on Core Body Temperature, Systolic Blood Pressure, Heart Rate, Postoperative Shivering, and Inflammation Response in Elderly Patients with Total Hip Replacement under Spinal Anesthesia: A Randomized Double-blind Controlled Trial (30분의 수술전 가온이 고관절 전치환술 노인 환자의 수술중 심부체온, 수축기압, 심박동수, 수술후 전율 및 염증반응에 미치는 효과)

  • Cheon, You Mi;Yoon, Haesang
    • Journal of Korean Academy of Nursing
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    • v.47 no.4
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    • pp.456-466
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    • 2017
  • Purpose: This study was designed to determine the effects of pre-warming on core body temperature (CBT) and hemodynamics from the induction of spinal anesthesia until 30 min postoperatively in surgical patients who undergo total hip replacement under spinal anesthesia. Our goal was to assess postoperative shivering and inflammatory response. Methods: Sixty-two surgical patients were recruited by informed notice. Data for this study were collected at a 1,300-bed university hospital in Incheon, South Korea from January 15 through November 15, 2013. Data on CBT, systemic blood pressure (SBP), and heart rate were measured from arrival in the pre-anesthesia room to 3 hours after the induction of spinal anesthesia. Shivering was measured for 30 minutes post-operatively. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were measured pre-operatively, and 1 and 2 days postoperatively. The 62 patients were randomly allocated to an experimental group (EG), which underwent pre-warming for 30 minutes, or a control group (CG), which did not undergo pre-warming. Results: Analysis of CBT from induction of spinal anesthesia to 3 hours after induction revealed significant interaction between group and time (F=3.85, p=.008). In addition, the incidence of shivering in the EG was lower than that in the CG ($x^2=6.15$, p=.013). However, analyses of SBP, heart rate, CRP, and ESR did not reveal significant interaction between time and group. Conclusion: Pre-warming for 30 minutes is effective in increasing CBT 2 and 3 hours after induction of spinal anesthesia. In addition, pre-warming is effective in decreasing post-operative shivering.

Effects of γ-aminobutyric acid-enriched fermented sea tangle (Laminaria japonica) on brain derived neurotrophic factor-related muscle growth and lipolysis in middle aged women

  • Choi, Wook-chul;Reid, Storm N.S.;Ryu, Je-kwang;Kim, Yunsook;Jo, Young-Hong;Jeon, Byeong Hwan
    • ALGAE
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    • v.31 no.2
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    • pp.175-187
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    • 2016
  • This study evaluated the effects of γ-aminobutyric acid (GABA)-enriched fermented sea tangle (GFST), as a functional food, on brain derived neurotrophic factor (BDNF)-related muscle growth and lipolysis, in a sarcopenic obesity high-risk group. Twenty-one middle-aged women (53-63 y) participated in this randomized, double-blind, placebo controlled study. Participants ingested either 1,000 mg of GFST (n = 10) or a sucrose placebo (CON) (n = 11) everyday, for 8 weeks. Subjects were asked to abstain from any regular exercise. Fasting venous blood samples, body composition and muscular strength were measured before and after supplementation period. Collectively, we demonstrated that GFST significantly decreased total fat mass and triglyceride in body composition, as well as significantly increasing serum BDNF (p < 0.001), angiotensin converting enzyme (p < 0.001), human growth hormone and insulin-like growth factor-1 levels (p < 0.05 and p < 0.05, respectively) accompanied by increased total lean mass (p < 0.01). Furthermore, the reported improvements in total work, knee extension and flexion at 60° s−1 (p < 0.05), and peak torque normalized to body weight of knee flexion at 60° s−1 (p < 0.05), support an ergogenic effect of GABA associated with increased growth factor levels. The use of GFST, as a functional food ingredient, to elicit anti-obesity effects and stimulate the release of muscle-related growth factors with increasing serum BDNF levels may provide a protective intervention for age-related degeneration such as sarcopenic obesity.

Effects of Korean Red Ginseng on Cognitive and Motor Function: A Double-blind, Randomized, Placebo-controlled Trial

  • Yeo, Hye-Bin;Yoon, Ho-Kyoung;Lee, Heon-Jeong;Kang, Seung-Gul;Jung, Ki-Young;Kim, Leen
    • Journal of Ginseng Research
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    • v.36 no.2
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    • pp.190-197
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    • 2012
  • Ginseng has a long history of use for health enhancement, and there is some evidence from animal studies that it has a beneficial effect on cognitive performance. The purpose of this study was to investigate the effect of Korean red ginseng on cognitive performance in humans. A total of 15 healthy young males with no psychiatric or cognitive problems were selected based on an interview with a board-certified psychiatrist. The subjects were randomly assigned to receive a daily dose of 4,500 mg red ginseng or placebo for a 2-week trial. There were 8 subjects in the red ginseng group and 7 subjects in the placebo group. All of the subjects were analyzed with the Vienna test system and a P300 event-related potential (ERP) test. There were no significant differences in the Vienna test system scores between the red ginseng group and the placebo group. In the event-related potential test, the C3 latency of the red ginseng group tended to decrease during the study period (p=0.005). After 2 wk, significant decreases were observed in the P300 latencies at Cz (p=0.008), C3 (p=0.005), C4 (p=0.002), and C mean (p=0.003) in the red ginseng group. Our results suggest that the decreased latency in ERP is associated with improved cognitive function. Further studies with a higher dosage of ginseng, a larger sample size, and a longer follow-up period are necessary to confirm the clinical efficacy of Korean red ginseng.

The Comparison Of Acupuncture Sensation Index Among Three Different Acupuncture Devices - Double-blind and Randomized Controlled Trial Method - (3개 침제조회사 침구(鍼具)에 대한 침감지표 비교 - 이중 맹검 무작위 배정법 -)

  • Lim, Seong-chul;Seo, Jung-chul;Kim, Kyung-un;Seo, Bo-myung;Kim, Sung-woong;Lee, Se-youn;Jung, Tae-young;Han, Sang-won;Lee, Hyun
    • Journal of Acupuncture Research
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    • v.21 no.6
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    • pp.209-219
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    • 2004
  • Objective : This study was designed to compare acupuncture sensation index among three different acupuncture devices. Methods : A, B and C acupuncture devices were inserted into Quchi(LI 11) of the subjects. After 5 minutes the subjects completed a questionnaire rating the intensity of 21 kinds of acupuncture sensation; hurting, penetrating, sharp, aching, intense, spreading, radiating, tingling, pricking, stinging, pulling, heavy, dull, numb, electric, shocking, hot, burning, cool, pulsing, and throbbing. We compared subjective evaluations of acupuncture sensation among the groups. Results : The acupuncture sensation index when administrated among three different acupuncture devices(A, B and C) was not significantly different. The acupuncture sensation of B acupuncture devices showed significant difference than A or C in Spreading, Dull, Numb item. But, the other items of acupuncture sensation were not significantly different among three acupuncture devices. Conclusions : We found that acupuncture sensation index when administrated among three different acupuncture devices. Further study is needed to know different acupuncture sensation among acupuncture devices.

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Comparison of Treatment Effects and Allergic responses to stiff neck between Sweet Bee Venom and Bee Venom Pharmacopuncture (A pilot study, Double blind, Randomized Controlled Clinical Trail) (락침(落枕) 환자에 대한 Sweet Bee Venom과 Bee Venom의 치료효과 및 Allergy 반응 비교 연구)

  • Lee, Kyoung-Hee;Youn, Hyoun-Min;Ko, Woo-Shin;Song, Choon-Ho;Jang, Kyung-Jeon;Ahn, Chang-Beohm;Kim, Cheol-Hong
    • Journal of Pharmacopuncture
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    • v.11 no.4
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    • pp.39-48
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    • 2008
  • Objective The purpose of this study is to investigate the difference of treatment effects and allergic responses to stiff neck between Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture. Methods Forty one patients who felt stiff neck were randomly divided into two groups, a Bee Venom Pharmacopuncture group(group I) and a Sweet Bee Venom Pharmacopuncture group(group II). Evaluations of the treatment effects were made before and after a treatment using Visual Analog Scale(VAS), Neck Disability Index(NDI), Clinical Evaluation Grade(CEG). The comparison of allergic responses was measured with VAS. The obtained data were analyzed and compared with SPSS. Results The group I and group II showed significant improvement(p<0.05) according to the VAS, NDI, CEG. And the differences between the two groups were insignificant according to VAS, NDI, CEG. But allergic responses such as localized edema, localized itching were significantly lower in group II than group I. Conclusions It seems that there are no big different treatment effects between the two groups. Sweet Bee Venom Pharmacopuncture appears to be more effective measurement against allergic reactions than the Bee Venom Pharmacopuncture. Further studies are needed for the comparison of Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture.

Fermented Whey Protein Supplementation Improves Muscular Strength, Muscle Parameters, and Physical Performance in Middle-Aged Korean Adults: An 8-Week Double Blind Randomized Controlled Trial

  • Cheol Hyun Kim;Yu Bin Jeon;Dong Gyu Yoo;Ki-Hong Kim;Hwan-Jong Jeong;Byung-Kwan Kim;Mi-Houn Park;Ki-Hwan Kim;Joon-Ho Hwang;Gun Hee Cho;Sung-Kyu Kim;Ki-Woong Lee;Sung-Han Kim
    • Food Science of Animal Resources
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    • v.43 no.3
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    • pp.512-530
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    • 2023
  • The present study evaluated the effects of fermented whey protein using kimchi lactic acid bacteria Lactobacillus casei DK211 on skeletal muscle mass, muscle strength, and physical performance in healthy middle-aged males performing regular resistance exercises. Effective protein supplementation and regular exercise are two important factors for improving muscle health. Therefore, in this study, the effects of consuming fermented whey protein twice a day were investigated and compared with that of non-fermented supplementation. Forty-eight males (average age 44.8) were randomly assigned to two groups: Fermented whey protein supplementation (FWPS) and non-fermented whey protein concentration supplementation (WPCS) groups. Each group ingested 37 g of FWPS or WPCS twice a day for eight weeks. Body composition, muscle strength, and physical performance were assessed pre- and post-intervention. Independent t-tests or chi-square tests for the categorical variables were performed for analyzing the observations. FWPS was effective in promoting the physical performance in dynamic balance measurement and muscle health, indicated through the increment in grip strength (left), upper arm circumference, and flat leg circumference from the baseline. However, similar improvements were not observed in the WPCS group. These results imply that whey protein fermented by L. casei DK211 is an effective protein supplement for enhancing muscle health in males performing regular resistance exercises.

A Pilot Clinical Study of the Efficacy and Safety of Phellinus Linteus (Sanghuang) Extract Treatment for Knee Osteoarthritis

  • Ryu, Hwa yeon;Lee, Hyun;Kang, Jae Hui
    • Journal of Acupuncture Research
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    • v.39 no.2
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    • pp.115-121
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    • 2022
  • Background: To evaluate the efficacy and safety of Phellinus linteus (PL) extract for the treatment of knee osteoarthritis (KOA) a pilot clinical study was performed. Methods: There were 24 patients with KOA who enrolled in this double-blind, randomized, controlled, clinical trial. There were 3 groups: PL 1,000 mg/day (PL 1,000), PL 1,500 mg/day (PL 1,500), and dextrin 3,000 mg/day (placebo). Patients took capsules twice a day, 3 capsules at a time, over 8 weeks. Patients were monitored prior to treatment (Visit 1: Week 0), and followed up every 4 weeks (Visit 2: Week 4 and Visit 3: Week 8) where outcome measurements were taken. The primary outcome measure was the score from the Korean version of the Western Ontario and McMasters Universities from baseline to Week 8. The secondary outcomes were measurements from the visual analog scale, quality of life scale, erythrocyte sedimentation, and c-reactive protein. Adverse events were recorded at every visit. Results: The Korean version of the Western Ontario and McMasters Universities score showed the greatest improvement in symptoms of KOA in the PL 1,500 group compared with the placebo group. The erythrocyte sedimentation tended to decrease in the PL 1,500 group compared with the placebo group (which was within the normal range). The visual analog scale score decreased in all groups, with no significant differences between groups. No adverse events related to PL were reported. There were no abnormal hematological or physical findings. Conclusion: This pilot clinical trial was the first step to assess the efficacy and safety of PL used in the treatment of patients with KOA.