• Title/Summary/Keyword: human trial

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Effect of sodium bicarbonate supplementation on two different performance indicators in sports: a systematic review with meta-analysis

  • Lino, Ramon Souza;Lagares, Laura Souza;Oliveira, Caio Victor Coutinho;Queiroz, Ciro Oliveira;Pinto, Lelia Lessa Teixeira;Almeida, Luiz Alberto Bastos;Bonfim, Eric Simas;dos Santos, Clarcson Placido Conceicao
    • Korean Journal of Exercise Nutrition
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    • v.25 no.1
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    • pp.7-15
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    • 2021
  • [Purpose] Sodium bicarbonate shows ergogenic potential in physical exercise and sports activities, although there is no strong evidence which performance markers show the greatest benefit from this supplement. This study evaluated the effects of sodium bicarbonate supplementation on time trial performance and time to exhaustion in athletes and sports practitioners. [Methods] A systematic review was conducted using three databases, including 17 clinical trials. Among these clinical trials, 11 were considered eligible for the meta-analysis according to the criteria for the assessment of methodological quality using the PEDro Scale. Time to exhaustion was assessed in six studies, while time trial performance was evaluated in five studies. [Results] A significant beneficial effect of supplementation on time to exhaustion was found in a random effects model (1.48; 95% confidence interval [CI], 0.49 to 2.48). There was no significant effect of supplementation on time trial performance in a fixed effects model (slope = -0.75; 95% CI, -2.04 to 0.55) relative to a placebo group. [Conclusion] Sodium bicarbonate has the potential to improve sports performance in general, especially in terms of time to exhaustion.

Safety and antifatigue effect of Korean Red Ginseng capsule: A randomized, double-blind and placebo-controlled clinical trial

  • Yang, Yi;Wang, Hong;Zhang, Ming;Shi, Mengxue;Yang, Cailing;Ni, Qiang;Wang, Qi;Li, Jing;Wang, Xuemei;Zhang, Chen;Li, Zhi
    • Journal of Ginseng Research
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    • v.46 no.4
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    • pp.543-549
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    • 2022
  • Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

Rice-based breakfast improves fasting glucose and HOMA-IR in Korean adolescents who skip breakfast, but breakfast skipping increases aromatic amino acids associated with diabetes prediction in Korean adolescents who skip breakfast: a randomized, parallel-group, controlled trial

  • Kim, Hyun Suk;Jung, Su-Jin;Jang, Soyoung;Kim, Min Jung;Cha, Youn-Soo
    • Nutrition Research and Practice
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    • v.16 no.4
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    • pp.450-463
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    • 2022
  • BACKGROUND/OBJECTIVES: Adolescents who skip breakfast have an increased prevalence of chronic diseases. Thus, we aimed to evaluate whether the intake of rice-based breakfast had positive effects on blood glucose indices and to determine the possibility of diabetes prevalence in Korean youths who habitually skip breakfast. SUBJECTS/METHODS: In this randomized parallel-group controlled trial, 81 subjects who were suitable for compliance among 105 middle-and high-school students aged 12-18 years who usually skipped breakfast were included in this study (rice-meal group [RMG], n = 26; wheat-meal group [WMG], n = 29; general-meal group [GMG], n = 26). The RMG and WMG received a rice-based breakfast and a wheat-based breakfast for 12 weeks, respectively. The anthropometric indices, blood glucose indices, and metabolites were measured at baseline and the endpoint, respectively. RESULTS: The mean body weights in the RMG, WMG, and GMG groups at the endpoint were 62.44 kg, 61.80 kg, and 60.28 kg, respectively, and the mean body weights of the WMG and GMG groups at the endpoint were significantly higher than that at baseline (P < 0.05). The levels of fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) values were significantly decreased in the RMG group at the endpoint compared to baseline (P < 0.05, P < 0.05, respectively). The levels of tryptophan and tyrosine in the WMG group at the endpoint were significantly higher than that those at baseline (P < 0.01, P < 0.05, respectively). CONCLUSIONS: Rice-based breakfast has positive effects on fasting insulin levels and HOMA-IR in Korean adolescents who skip breakfast. Additionally, it was found that a skipping breakfast could increase the prevalence of diabetes in adolescents who skip breakfast. Therefore, in addition to reducing breakfast skipping, it is vital to develop a rice-based menu that fits teenage preferences to prevent chronic diseases such as diabetes.

Handling dependencies among performance shaping factors in SPARH through DEMATEL method

  • Zhihui Xu;Shuwen Shang;Xiaoyan Su;Hong Qian;Xiaolei Pan
    • Nuclear Engineering and Technology
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    • v.55 no.8
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    • pp.2897-2904
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    • 2023
  • The Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method is a widely used method in human reliability analysis (HRA). Performance shaping factors (PSFs) refer to the factors that may influence human performance and are used to adjust nominal human error probabilities (HEPs) in SPAR-H. However, the PSFs are assumed to be independent, which is unrealistic and can lead to unreasonable estimation of HEPs. In this paper, a new method is proposed to handle the dependencies among PSFs in SPAR-H to obtain more reasonable results. Firstly, the dependencies among PSFs are analyzed by using decision-making trial and evaluation laboratory (DEMATEL) method. Then, PSFs are assigned different weights according to their dependent relationships. Finally, multipliers of PSFs are modified based on the relative weights of PSFs. A case study is illustrated that the proposed method is effective in handling the dependent PSFs in SPAR-H, where the duplicate calculations of the dependent part can be reduced. The proposed method can deal with a more general situation that PSFs are dependent, and can provide more reasonable results.

A Systematic review for the development of cosmetic clinical trial protocol (화장품 임상시험 프로토콜 개발을 위한 체계적 문헌 고찰)

  • Jo, Ga-Won;Hwang, Chung-Yeon;Hong, Seok-Hoon;Kim, Nam-Kwen
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.1
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    • pp.104-117
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    • 2013
  • Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

Understanding of Clinical Trials and Application to the Real Practice (임상시험의 단계별 이해 및 실제)

  • Choi, SungKu
    • Korean Journal of Biological Psychiatry
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    • v.19 no.4
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    • pp.153-158
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    • 2012
  • Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

Tentative identification of 20(S)-protopanaxadiol metabolites in human plasma and urine using ultra-performance liquid chromatography coupled with triple quadrupole time-of-flight mass spectrometry

  • Ling, Jin;Yu, Yingjia;Long, Jiakun;Li, Yan;Jiang, Jiebing;Wang, Liping;Xu, Changjiang;Duan, Gengli
    • Journal of Ginseng Research
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    • v.43 no.4
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    • pp.539-549
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    • 2019
  • Background: 20(S)-Protopanaxadiol (PPD), the aglycone part of 20(S)-protopanaxadiol ginsenosides, possesses antidepressant activity among many other pharmacological activities. It is currently undergoing clinical trial in China as an antidepressant. Methods: In this study, an ultra-performance liquid chromatography coupled with triple quadrupole time-of-flight mass tandem mass spectrometry method was established to identify the metabolites of PPD in human plasma and urine following oral administration in phase IIa clinical trial. Results: A total of 40 metabolites in human plasma and urine were identified using this method. Four metabolites identified were isolated from rat feces, and two of them were analyzed by NMR to elucidate the exact structures. The structures of isolated compounds were confirmed as (20S,24S)-epoxydammarane-12,23,25-triol-3-one and (20S,24S)-epoxydammarane-3,12,23,25-tetrol. Both compounds were found as metabolites in human for the first time. Upon comparing our findings with the findings of the in vitro study of PPD metabolism in human liver microsomes and human hepatocytes, metabolites with m/z 475.3783 and phase II metabolites were not found in our study whereas metabolites with m/z 505.3530, 523.3641, and 525.3788 were exclusively detected in our experiments. Conclusion: The metabolites identified using ultra-performance liquid chromatography coupled with triple quadrupole time-of-flight mass spectrometry in our study were mostly hydroxylated metabolites. This indicated that PPD was metabolized in human body mainly through phase I hepatic metabolism. The main metabolites are in 20,24-oxide form with multiple hydroxylation sites. Finally, the metabolic pathways of PPD in vivo (human) were proposed based on structural analysis.