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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients with Mild to Moderate Alzheimer's Disease Treated with Donepezil: DHP1401 Randomized Trial in Mild to Moderate Alzheimer's Disease (DRAMA).
Shim, Y, Han, HJ, Park, KW, Kim, BC, Park, KH, Park, MY, Kim, HJ, Moon, SY, Choi, SH, Park, KW, et al
Journal of Alzheimer's disease : JAD. 2022;(1):391-403
Abstract
BACKGROUND Preclinical studies in transgenic models of Alzheimer's disease (AD) suggest that DHP1401 has neuroprotective and memory-enhancing effects. OBJECTIVE To evaluate the efficacy and safety of DHP1401 in AD patients treated with donepezilMethods:Methods: In a double-blind study, patients with mild-to-moderate AD were randomized (1:1:1) to receive a twice daily total dose of 500 mg or 1000 mg DHP1401 or placebo for 24 weeks. Tolerability and safety were monitored at baseline and weeks 12 and 24. RESULTS total of 180 patients were randomized to Active 1 (500 mg: n = 62), Active 2 (1000 mg: n = 53), and control groups (n = 65) in 16 sites in Korea. There was no significant difference in the Alzheimer's Disease Assessment Scale (ADAS-cog) score, the primary efficacy endpoint, from baseline. However, in the subgroup with mild AD patients (MMSE, 20-26) who received the high dose of DHP1401 and the group that received donepezil 5 mg, the ADAS-cog scores improved. MMSE and K-TMT-e type B were significant in both active groups at week 24. The most frequently observed symptom was dizziness (2.78%), and the most commonly observed reactions were related to metabolism and nutrition disorders (5.00%). No remarkable adverse events were observed for 24 weeks. CONCLUSION Although the effectiveness of DHP1401 was not proved to be superior as the primary efficacy endpoint, the secondary endpoints, MMSE and K-TMT-e type B, showed significant beneficial effects. Also, the subgroups showed that ADAS-cog scores significantly were improved. DHP1401 could be proven beneficial for the AD treatment by further clinical trials.
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Effects of branched-chain amino acids on postoperative tumor recurrence in patients undergoing curative resection for hepatocellular carcinoma: A randomized clinical trial.
Hachiya, H, Aoki, T, Iso, Y, Shimizu, T, Tago, K, Park, KH, Sakuraoka, Y, Shiraki, T, Mori, S, Kubota, K
Journal of hepato-biliary-pancreatic sciences. 2020;(11):819-829
Abstract
BACKGROUND/PURPOSE No effective postoperative adjuvant therapies have been established for patients with hepatocellular carcinoma (HCC). The aim of this study was to investigate the effect of oral administration of branched-chain amino acids (BCAA) on the recurrence-free survival (RFS) after hepatic resection in HCC patients. METHODS In this randomized clinical trial, HCC patients undergoing curative resections were randomly assigned in a 1:1 ratio to the BCAA group or surgery-alone group. The BCAA group received BCAA (Livact® ) for up to 4 years. The primary endpoint was RFS. The secondary endpoint was overall survival (OS). Multivariate analysis was performed to detect the clinical characteristics significantly associated with RFS. RESULTS Between January 2010 and October 2014, 156 patients (75 in BCAA group and 81 in surgery-alone group) were enrolled in the study. Of these, two patients were excluded from the efficacy analysis. Comparison of the survival curves by the log rank test demonstrated no significant difference in the RFS (P = .579) or OS (P = .268) between the BCAA and the control group. Multivariate analysis revealed that the RFS was significantly associated with age and number of tumors. A beneficial effect of BCAA on the RFS was found in patients younger than 72 years old with a HbA1c level of < 6.4%. CONCLUSIONS Oral BCAA supplementation could not reduce the risk of recurrence after hepatic resection in HCC patients; however, the results suggested that BCAA supplementation may be beneficial for selected patients who were younger and had mildly impaired glucose tolerance.
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A 24-week intervention based on nutrition care process improves diet quality, body mass index, and motivation in children and adolescents with obesity.
Lee, SY, Kim, J, Oh, S, Kim, Y, Woo, S, Jang, HB, Lee, HJ, Park, SI, Park, KH, Lim, H
Nutrition research (New York, N.Y.). 2020;:53-62
Abstract
Higher motivation could support to lead behavioral change for obese children and adolescents. This study aimed to evaluate the effects of a nutrition care process (NCP)-based intervention targeted on diet and weight status in moderate to severe obese children and adolescents in Korea. One hundred four subjects (mean age: 10.95 years, body mass index (BMI) ≥97th percentile of age-sex) participated in the present study. Subjects were divided into a usual care group (UG) and a nutrition group (NG). All participants underwent nutrition education 6 times. The NG received individual access and continuous monitoring and setting goals with respect to nutritional problems. Consumption of high-calorie, low-nutrient (HCLN) food was significantly decreased (P < .05) and the Diet Quality Index-International (DQI-I) score also increased with respect to sodium (P < .001). The total self-efficacy score was increased from 9.15 to 10.14 points (P < .01). After 24 weeks, the BMI-z-score decreased from 2.27 to 2.19 in the NG (P < .05); however, no group difference was found. BMI-z-score was negatively associated with self-efficacy (β = -0.03, P < .019). NCP-based intervention might be helpful to solve dietary problems by enhancing self-efficacy and lower BMI-z-score in moderately to severely obese children and adolescents.
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Lifestyle counselling by persuasive information and communications technology reduces prevalence of metabolic syndrome in a dose-response manner: a randomized clinical trial (PrevMetSyn).
Seo, YG, Salonurmi, T, Jokelainen, T, Karppinen, P, Teeriniemi, AM, Han, J, Park, KH, Oinas-Kukkonen, H, Savolainen, MJ
Annals of medicine. 2020;(6):321-330
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Abstract
OBJECTIVES The aim was to investigate whether lifestyle changes produced by persuasive Information and Communication Technology (ICT) counselling can lower the prevalence of metabolic syndrome (MetS). METHODS A total of 532 participants (20-60 years, body mass index 27-35 kg/m2) were randomly assigned to six arms according to counselling type (no, short-term, or intensive) with or without ICT intervention. In this report the prevalence of MetS and its components were compared between no-ICT group and ICT group. Moreover, the frequency of the web information system usage was analysed for the number of logins, responses to weekly messages, and other record variables. RESULTS The ICT group had significantly lower proportion of MetS (33.7% vs. 45.3%, p = .022) than the no-ICT group at 2-year follow-up. In mixed model, the ICT group had lower prevalence of MetS than no-ICT group (OR 0.50, 95%CI 0.27-0.90) after intervention. The tertile with the highest utilization had 71% lower prevalence of MetS compared with the lowest utilization tertile or the no-ICT group. CONCLUSIONS Web-based ICT is able to reduce the prevalence of MetS. In addition, higher utilization of the web information system is associated with a greater decrease in the prevalence of MetS. Key messages Our internet health behaviour change support system based on persuasive design and cognitive behaviour therapy markedly reduces metabolic syndrome in overweight/obese subjects. As a stand-alone tool it may save healthcare personnel resources as it is suitable at a low cost for both obese/overweight patients and the public at large.
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The Effect of a Multidisciplinary Lifestyle Intervention on Obesity Status, Body Composition, Physical Fitness, and Cardiometabolic Risk Markers in Children and Adolescents with Obesity.
Seo, YG, Lim, H, Kim, Y, Ju, YS, Lee, HJ, Jang, HB, Park, SI, Park, KH
Nutrients. 2019;11(1)
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Plain language summary
Children and adolescents with obesity are at a high risk of being obese in adulthood. The aim of this study was to develop a multidisciplinary lifestyle intervention program targeted at children and adolescents with moderate to severe obesity. The study is based on the Intervention for Childhood and Adolescents Obesity via Activity and Nutrition (ICAAN) – quasi-experimental intervention trial - which recruited 103 participants aged between 6 and sixteen years (63 were boys and 40 girls). The study was based on 2 active treatment groups (usual care group vs exercise group) receiving a 16-week intervention program. Results indicate that children and adolescents with obesity can achieve positive effects on body composition, physical fitness, and cardiometabolic markers, particularly with the exercise intervention. Authors conclude that the moderate-intensity multidisciplinary lifestyle intervention program they developed, can be sustained in the real-world setting and it is applicable to both moderate and severe obesity.
Abstract
This study aimed to develop a multidisciplinary lifestyle intervention program targeted at children and adolescents with moderate to severe obesity, and assess the additional effects of exercise intervention when compared to usual care. Overall, the 103 enrolled participants were ≥85th percentile of age and sex-specific body mass index (BMI). Participants were divided into groups that received 16 weeks of either usual care or exercise intervention. The BMI z-score of the overall completers decreased by about 0.05 after the 16-week intervention (p = 0.02). After the intervention, only the exercise group had a significantly lower BMI z-score than the baseline score by about 0.1 (p = 0.03), but no significant group by time interaction effects were observed. At the 16-week follow-up, significant group by time interaction effects were observed in percentage body fat (%BF) (β = -1.52, 95%CI = -2.58⁻-0.45), lean body mass (LM) (β = 1.20, 95%CI = 0.12⁻2.29), diastolic blood pressure (β = -5.24, 95%CI = -9.66⁻-0.83), high-sensitivity C-reactive protein (β = -1.67, 95%CI = -2.77⁻-1.01), and wall sit test score (β = 50.74, 95%CI = 32.30⁻69.18). We developed a moderate-intensity intervention program that can be sustained in the real-world setting and is practically applicable to both moderate and severe obesity. After interventions, the exercise group had lower %BF and cardiometabolic risk markers, and higher LM and leg muscle strength compared to the usual care group.
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Rivaroxaban after Thrombolysis in Acute Iliofemoral Venous Thrombosis: A Randomized, Open-labeled, Multicenter Trial.
Kang, JM, Park, KH, Ahn, S, Cho, S, Han, A, Lee, T, Jung, IM, Kim, JY, Min, SK
Scientific reports. 2019;(1):20356
Abstract
Recently non-Vitamin K antagonist oral anticoagulants (NOAC) is replacing warfarin for the treatment of deep vein thrombosis (DVT). However, the role of NOAC after thrombolysis of acute iliofeomral DVT (IFDVT) is not yet defined. This randomized clinical trial aimed to compare the safety and efficacy of rivaroxaban versus warfarin after catheter directed thrombolysis of an IFDVT. Patients with acute DVT of both the iliac and the femoral vein (n = 72) were recruited and randomized to either standard anticoagulation (enoxaparin and warfarin, n = 35) or rivaroxaban (n = 37) after successful thrombolysis or mechanical thrombectomy. Primary efficacy outcome was a recurrence of any venous thromboembolism (VTE) within 6 months. Secondary safety outcomes included major bleeding, clinically relevant non-major bleeding (CRNMB), other adverse event, and all-cause mortality. Rate of recurrent VTE were similar in both groups (11.4% versus 12.5%; p = 0.94). Major bleeding or CRNMB was less in rivaroxaban group without significance (2.9% versus 9.4%, HR, 0.31; 95% CI, 0.03-2.96; p = 0.31). Recurrence-free survival and major bleeding-free survival at 6 months were not different in both groups. After thrombolysis of acute IFDVT, rivaroxaban was as safe and effective as warfarin in preventing DVT recurrence.
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A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors.
Yun, YH, Kim, YA, Lee, MK, Sim, JA, Nam, BH, Kim, S, Lee, ES, Noh, DY, Lim, JY, Kim, S, et al
BMC cancer. 2017;(1):298
Abstract
BACKGROUND We aimed to evaluate the potential benefits of the Leadership and Coaching for Health (LEACH) program on physical activity (PA), dietary habits, and distress management in cancer survivors. METHODS We randomly assigned 248 cancer survivors with an allocation ratio of two-to-one to the LEACH program (LP) group, coached by long-term survivors, or the usual care (UC) group. At baseline, 3, 6, and 12 months, we used PA scores, the intake of vegetables and fruits (VF), and the Post Traumatic Growth Inventory (PTGI) as primary outcomes and, for secondary outcomes, the Ten Rules for Highly Effective Health Behavior adhered to and quality of life (QOL), the Hospital Anxiety and Depression Scale (HADS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). RESULTS For primary outcomes, the two groups did not significantly differ in PA scores or VF intake but differed marginally in PTGI. For secondary outcomes, the LP group showed a significantly greater improvement in the HADS anxiety score, the social functioning score, and the appetite loss and financial difficulties scores of the EORTC QLQ-C30 scales from baseline to 3 months. From baseline to 12 months, the LP group showed a significantly greater decrease in the EORTC QLQ-C30 fatigue score and a significantly greater increase in the number of the Ten Rules for Highly Effective Health Behavior. CONCLUSION Our findings indicate that the LEACH program, coached by long-term survivors, can provide effective management of the QOL of cancer survivors but not of their PA or dietary habits. TRIAL REGISTRATION Clinical trial information can be found for the following: NCT01527409 (the date when the trial was registered: February 2012).
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Circulating irisin levels are not affected by coffee intake: a randomized controlled trial.
Peter, PR, Park, KH, Huh, JY, Wedick, NM, Mantzoros, CS
PloS one. 2014;(4):e94463
Abstract
UNLABELLED Irisin, secreted by skeletal muscle and possibly fat, is hypothesized to play an important role in modulating energy expenditure, obesity and metabolism. Coffee consumption also increases energy expenditure and leads to positive metabolic effects, but whether these effects are mediated by irisin remains unknown. The objective of this study was to determine the association between baseline irisin levels and the metabolic profile in humans and to investigate whether consumption of caffeinated coffee alters irisin levels. To this end, a secondary analysis was performed investigating irisin levels at baseline and after eight weeks in 32 healthy, overweight coffee drinkers who were randomized to consumption of 5 cups per day of instant caffeinated coffee, decaffeinated coffee, or water. Spearman correlation and analysis of covariance analyses were performed to identify possible associations. Irisin levels were positively correlated with waist circumference (r = 0.41, p = 0.02), fat mass (r = 0.44, p = 0.01) and CRP (r = 0.47, p = 0.007). Though there was a trend towards increased levels of irisin over time in the caffeinated coffee group (+1.8%) when compared to the placebo group (24%) this did not reach statistical significance (p = 0.75 for the trend). This first randomized trial failed to reveal any effects of coffee consumption on irisin levels, but a larger trial, appropriately sized on the basis of data provided by this study, is needed to conclusively investigate such a relationship. TRIAL REGISTRATION Clinicaltrials.gov NCT00305097.
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Prevalence, risk factors and comorbidities of allergic rhinitis in South Korea: The Fifth Korea National Health and Nutrition Examination Survey.
Rhee, CS, Wee, JH, Ahn, JC, Lee, WH, Tan, KL, Ahn, S, Lee, JH, Lee, CH, Cho, YS, Park, KH, et al
American journal of rhinology & allergy. 2014;(2):e107-14
Abstract
BACKGROUND There has been no nationwide epidemiological investigation of allergic rhinitis (AR) that was diagnosed by both questionnaires and laboratory tests in Korea. This study investigated the prevalence, risk factors, and comorbidities of AR in South Korea. METHODS The Korean National Health and Nutritional Examination Survey examined a representative sample of the Korean population. A total of 2305 participants underwent immunoradiometric assay for specific IgE antibodies against common indoor allergens. Healthy, atopy only, and AR groups were defined according to the results of allergen test. The weighted prevalence for each group was calculated. Risk factors including food and comorbidities were identified using univariate or multivariate analyses. The patients were also categorized into four subgroups according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification and associated comorbidities were analyzed. RESULTS The prevalence of atopy only and AR was 30.0 ± 1.2% and 16.2 ± 1.0%, respectively. The multivariate analysis showed that the prevalence was influenced by sex (p < 0.01) for atopy only and sex (p = 0.09), age (p = 0.02), marital status (p = 0.24), and stress level (p = 0.30) for AR. Compared with the healthy group, asthma (odds ratio [OR] = 4.77), nasal polyp (NP; OR = 3.44), chronic rhinosinusitis (OR = 13.93), and olfactory dysfunction (OR = 4.88) were more prevalent in the AR group. Based on the ARIA guideline, intermittent mild rhinitis was most common (58.1%). Asthma was correlated to severity and atopic dermatitis and NPs was associated with persistency. Daily intake of less mackerel and more carrots, bread, and bean curd were associated with the increased risk of AR. CONCLUSION Prevalence, risk factors, and comorbidities of AR were evaluated in the general Korean population, which will contribute to prevention and treatment of AR and its comorbidities in Koreans.
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Effect of menatetrenone, a vitamin k2 analog, on recurrence of hepatocellular carcinoma after surgical resection: a prospective randomized controlled trial.
Ishizuka, M, Kubota, K, Shimoda, M, Kita, J, Kato, M, Park, KH, Shiraki, T
Anticancer research. 2012;(12):5415-20
Abstract
The aim of this study was to investigate whether menatetrenone (MNT) suppresses hepatocellular carcinoma (HCC) recurrence in patients undergoing hepatectomy. Between January 2005 and September 2009, 101 patients who underwent curative hepatectomy for primary HCC were enrolled in the study. Patients were divided into two groups: a non-MNT group (n=51), and an MNT group (n=50) that was administered 45 mg of MNT daily. During the observation period, recurrence was observed in 33 patients in the non-MNT group and in 28 patients of the MNT group (p=0.545). In patients with a preoperative Des-γ-carboxy-prothrombin (DCP) level lower than 40 AU/l (n=38), the cumulative disease-free survival rates at 12, 36, and 60 months in the non-MNT group, were 81.3%, 0.0%, and 0.0%, respectively, while those in the MNT group were 78.3%, 58.1%, and 31.0%, respectively (p=0.060). MNT has a moderately suppressive effect on HCC recurrence after hepatectomy, especially in patients with a normal preoperative DCP level.