• Nutrition Research and Practice
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• v.10 no.2
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• pp.175-181
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• 2016

BACKGROUND/OBJECTIVES: The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS: In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS: Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS: Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects.

• Nutrition Research and Practice
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• v.11 no.3
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• pp.223-231
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• 2017

BACKGROUND/OBJECTIVES: Soy isoflavones are expected to improve menopausal symptoms and osteoporosis in women. However, their efficacy is still inconclusive, and there was limited data for postmenopausal women in South Korea. We examined the effects of soy isoflavones on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women. SUBJECTS/METHODS: A randomized, double-blind study design was used. Eighty-seven participants who had undergone natural menopause were randomly administered either 70 mg/day isoflavones (n = 43) or placebo (n = 41) for 12 weeks. We assessed the Kupperman index for climacteric symptoms and the menopause-specific quality of life (MENQOL) questionnaire for quality of the life. Biomarkers of bone metabolism were also measured in serum bone-specific alkaline phosphatase (BALP), osteocalcin (OC), N- and C-terminal cross-linking telopeptides of type Ι collagen (NTx, CTx), and urine-deoxypyridinolin (u-DPD). RESULTS: Scores of the Kupperman index were decreased in both the isoflavones group ($-7.0{\pm}15.8$, P = 0.0074) and placebo group ($-6.3{\pm}14.6$, P = 0.0064) during the intervention, but no significant difference was noted between the groups. Regarding the bone formation markers, the level of serum BALP increased by $6.3{\pm}4.1%$ (P = 0.004) and OC increased by $9.3{\pm}6.2%$ (P < 0.001), meanwhile those of the placebo were not changed. For the bone resorption markers, NTx, CTx, and u-DPD were not significantly different in either group. MENQOL was significant decreased in the isoflavone group ($-0.6{\pm}0.5$) and placebo group ($-0.6{\pm}0.4$), with a significant difference between groups (P = 0.0228). CONCLUSIONS: Our study suggests that 70 mg isoflavones supplement has beneficial effects on bone formation markers; however, it showed no benefit compared to the placebo on climacteric symptoms or quality of life.

• Journal of Pharmaceutical Investigation
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• v.27 no.4
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• pp.331-335
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• 1997

Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

• Korean Journal of Psychosomatic Medicine
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• v.5 no.2
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• pp.195-204
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• 1997

Objectives : The behavioral and physiological effects following low doses and high doses of melatonin have not been fully explored. In this study the authors investigated the nature and extent of the hypnotic effects, oral temperature, blood pressure effects, performance effects and subjective feelings following the acute administration of low pharmacological oral doses of melatonin at mid-day. Methods : Thirty-five healthy young medical students were randomly assigned to receive 6mg of oral melatonin(N=11), 12mg of oral melatonin(N=12) or a placebo(N=12) in a double-blind, placebo controlled trial. Measures of the behavioral and physiological effects used in the study were Stanford Sleepiness Scale, Digit Symbol Substitution Test, Trail test and visual analogue scale for subjective feelings. Oral temperature and blood pressure were measured. The subjects were studied between 10:00 and 16:00 hours. Data were analyzed by using repeated-measures analyses of variance(ANOVA). Results: Melatonin produced statistically significant effects on oral temperature, but there were no significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on oral temperature between the 12mg oral melatonin group and the placebo group at 12:00 and 16:00 hours, but no significant difference between the 12mg and the 6mg oral melatonin groups. Melatonin produced a dose-related increase in subjective sleepiness and had significant effects on time, the $dose{\times}time$ interaction. There was a significant difference on subjective sleepiness among the placebo, 6mg, 12mg oral melatonin groups at 13:00-16:00 hours. Melatonin did not produce statistically significant dose-related effects on subjective fatigue but produced significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on subjective fatigue between the 12mg, the 6mg oral melatonin groups and the placebo group at 13:00 hour. Conclusions : These data indicated that acute administration of melatonin at mid-day increased subjective sleepiness and fatigue but decreased oral temperatures. These effects were shown especially in 12mg oral melatonin group.

• Nutrition Research and Practice
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• v.5 no.1
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• pp.28-33
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• 2011

Limited information from human studies indicates that dietary quercetin supplementation influences blood lipid profiles, glycemic response, and inflammatory status, collectively termed cardiometabolic risks. We tested the hypothesis that quercetin-rich supplementation, derived from onion peel extract, improves cardiometabolic risk components in healthy male smokers in a randomized, double blinded, placebo-controlled parallel design. Randomly assigned subjects were instructed to take either the placebo (n=43) or 100 mg quercetin capsules each day (n=49) for 10 weeks. Anthropometric parameters and blood pressure were measured, and blood lipids, glucose, interleukin-6, and soluble vascular cell adhesion molecule-1 (sVCAM-1) were determined at baseline and after 10 weeks of quercetin supplementation. Quercetin-rich supplementation significantly reduced serum concentrations of total cholesterol (P<0.05) and LDL-cholesterol (P<0.01), whereas these effects were not shown in the placebo group. Furthermore, significant increases were observed in serum concentrations of HDL-cholesterol both in the placebo (P<0.005) and quercetin-rich supplementation group (P<0.001); however, changes in HDL-cholesterol were significantly greater in subjects receiving quercetin-rich supplementation than the placebo. Both systolic (P<0.05) and diastolic blood pressure (P<0.01) decreased significantly in the quercetin-rich supplementation group. Glucose concentrations decreased significantly after 10 weeks of quercetin-rich supplementation (P<0.05). In contrast, no effects of quercetin-rich supplementation were observed for the inflammatory markers-IL-6 and sVCAM-1. Daily quercetin-rich supplementation from onion peel extract improved blood lipid profiles, glucose, and blood pressure, suggesting a beneficial role for quercetin as a preventive measure against cardiovascular risk.

• The Korean Journal of Physiology and Pharmacology
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• v.13 no.1
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• pp.33-37
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• 2009

Anti-inflammatory factor(AIF) is a water soluble extract of three herbs, Panax notoginseng(Burk.) F. H. Chen, Rehmannia glutinosa Libosch and Eleutherococcus senticosus. The present study aimed to investigate the safety and efficacy of herb extracts, AIF, on Korean knee osteoarthritis patients for six weeks. Fifty seven patients with knee osteoarthritis, ranging from 43 to 73 years of age, who fulfilled the "American College of Rheumatology"(ACR) classification of idiopathic osteoarthritis of knee and radiographic criteria were randomly selected and enrolled for the study. After initial screening and resting period, two capsules each of AIF(Each capsule contains; 400 mg) and similar identical placebo were administered twice a day to both groups. Pain intensity at second, fourth, and sixth weeks of study as well as one week after discontinuation of drugs was assessed by using 100 mm visual analogue scale(VAS). Changes in the Korean version of the Western Ontario and McMaster Universities(K-WOMAC) index score were compared at the initiation and completion of the study. VAS assessed by patients were significantly reduced(at visit 2; $54.64{\pm}14.72$, at visit 4, $37.32{\pm}16.58$, p<0.001) after AIF administration. Results showed an improvement in the physical function of K-WOMAC scale which was significantly higher(p=0.013) in AIF than placebo group, and decreases of total K-WOMAC score were also significantly higher(p=0.030) in AIF groups than placebo group. No serious adverse effect was observed, and there was no difference in incidence of adverse effect between AIF and placebo groups. In this population of Korean patients with knee osteoarthritis, AIF was found to be safe, tolerable and effective for symptomatic improvement of pain and physical function.

• 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.

• Journal of Korean Academy of Fundamentals of Nursing
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• v.3 no.1
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• pp.7-18
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• 1996

This study was performed to evaluate the effect of placebo(emotional stimulus) on physical fitness and psychological wellbeing. The subjects for the study were devided into two groups. One experimental group received placebo and the other control group did not receive. Each group was composed of 15 women. The subjects continued aerobic exercise for an hour each time, three times a week, for eight weeks. The enhancement of physical fitness has been evaluated by body weight, BP, pulse rate, skinfold thickness, circumference of waist and hip, body fat, % body fat, lean body mass, % lean body mass they were measured three times every 4 weeks. Also to evaluate the enhancement of psychological wellbeing, the self-esteem and self-perception were measured. The results can be summarized as follows : 1. The % body fat of experimental group decreased significantly than that of control group(p<0.1). 2. The % lean body mass of experimental group decreased significantly than that of control group(p<0.1). 3. There was no significant difference of other physical fitness factors between experimental group and control group. 4. There was no significant difference of self-esteem between experimental group and control group. 5. There was no significant difference of self-perception between experimental group and control group. From these results, it may be concluded that placebo(emotional stimulus) which received during aerobic exercise period is partially effective in the enhancement of the physical fitness.

• The Journal of Internal Korean Medicine
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• v.29 no.3
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• pp.800-809
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• 2008

Objective : Although chronic prostatitis/chronic pelvic pain syndrcme(CP/CPPS) is a common disease, there is no consensus on the etiology or pathology and treatment. This was a double-blinded, placebo-controlled, randomized clinical trial, investigating the therapeutic effects of the traditional Korean medicine, Bosingunyang-tang(BSGYT). Method : Participants who met US National Institutes of Health (NIH) consensus criteria for CP/CPPS were entered after applying inclusion/exclusion criteria. They were randomized to the BSGYT or placebo group. and treated three times a day for 6 weeks. NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was used to estimate the clinical symptoms of CP/CPPS. Prostaglandin E2 and ${\beta}$-endorphin in prostatic fluid, collected by 2-glass pre-massage and post-massage test, were analyzed as factors associated with pain and inflammation. Result : The mean decrease in NIH-CPSI total score of the BSGYT group was 11.0 points, which is 5.7 points more than the placebo group. (Mann Whitney test P=0.038) Also the BSGYT group showed three times higher response rate than the placebo group in NIH-CPSI pain subscale score. (Fisher's exact test P=0.027) In those responders, prostaglandin E2 decreased significantly. (Wilcoxon's signed-ranks test P=0.037). No specific side effects were observed. Conclusion : After a 6-week treatment period, BSGYT improved clinical symptoms of CP/CPPS patients by decreasing PGE2 level in prostatic fluid.

• Journal of Periodontal and Implant Science
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• v.27 no.4
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• pp.701-722
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• 1997

It was reported that low dose doxycycline(LDD) regimen could inhibit pathologically elevated collagenase activity in the gingival crevicular fluid of petients with adult periodontitis without producing typical antibiotic side effects. The purpose of this study was to evaluate the effects of LDD regimen(20mg) administered during non-surgical therapy on clinical index and gingival crevicular fluid enzyme activity in diabetics who are at high risk for periodontal disease. Forty-nine subjects having at least two sites with probing pocket depths greater than 4mm were selected. In this double-blind, placebo-controlled study, the patients were administered 20 mg doxycycline capsule or placebo capsule b.i.d. for 2 weeks. Clinical parameters of dental plaque, gingival inflammation, probing pocket depth and probing attachment level were assessed at week 0, 2, 4, and 8. Gingival crevicular fluid samples were collected at the same time to evaluate the activities of collagenase and elastase. Clinical parameters and elastase activity were significantly reduced in all groups compared to the baseline value after treatment. Significantly greater reduction in pocket depth and gain in attachment level was shown in the LDD-administered group compared to placebo group in both adult periodontitis and diabetic patients. Total collagenase activity was also reduced significantly in all groups after treatment, but the greater reduction was seen in the LDD-administered diabetics group compared to relevant placebo group(at 4, 8week). Significantly greater reduction in active collagenase activity was also seen in the LDD-administered group compared to placebo group in diabetic patients(at 2, 4, 8week). These results indicated that use of low dose doxycycline could be aueseful adjunct to instrumentation therapy in the management of diabetic patient with periodontitis as well as adult periodontitis patient.