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Evaluation of Mangosteen juice blend on biomarkers of inflammation in obese subjects: a pilot, dose finding study

机译:评估山竹果汁混合物对肥胖受试者炎症生物标志物的作用:一项试验,剂量发现研究

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Background The ability to reduce inflammation in overweight and obese individuals may be valuable in preventing the progression to metabolic syndrome with associated risks for heart disease and diabetes. The purpose of this study was to evaluate the effect of multiple dosages of a proprietary Mangosteen Juice blend on indicators of inflammation and antioxidant levels in obese patients with elevated C-reactive protein (CRP) levels. Methods The study was an 8 week randomized, double-blind, placebo-controlled study with a pre-study 2 week washout period. The study included four groups including placebo and three difference doses of the test product, XanGo Juice?: 3, 6 or 9 oz twice daily. The primary outcome measure of this study was high-sensitivity (HS)-CRP. Secondary outcome measures included other biochemical indicators of inflammation, anthropomorphic measures and a safety evaluation. Results One hundred twenty two (122) persons were screened for the study, 44 were randomized and 40 completed the study. HS-CRP measurements dropped after 8 weeks treatment compared to baseline in all 3 dose groups and increased in the placebo group. The changes from baseline were not significant but the comparison of change from baseline was significant for the 18 oz group when compared to placebo (p = 0.02). Other markers of inflammation (inflammatory cytokines) and a marker for lipid peroxidation (F2 isoprostane) did not show any significant differences when compared with placebo. There was a trend towards a decrease in BMI in the juice groups. There were no side effects reported in any of the groups and none of the laboratory or EKG safety assessments indicated clinically significant changes for any subject. Conclusion In this pilot, dose-finding study, a proprietary mangosteen juice blend (XanGo Juice?) reduced CRP levels (increased change from baseline) compared to placebo for those taking the highest dose of 18 oz per day. Further studies with a larger population are required to confirm and further define the benefits of this juice. The juice was administered safely. Trial Registration ISRCTN9300027
机译:背景技术减轻超重和肥胖个体的炎症的能力可能在预防发展为具有心脏病和糖尿病相关风险的代谢综合症方面很有价值。这项研究的目的是评估多剂量的专有山竹果汁混合剂对肥胖的C反应蛋白(CRP)水平升高的患者的炎症和抗氧化指标的影响。方法该研究是一项为期8周,随机,双盲,安慰剂对照的研究,研究期为2周。该研究包括四组,包括安慰剂和三种不同剂量的测试产品XanGo Juice ?:每天两次,3盎司,6盎司或9盎司。这项研究的主要结局指标是高敏感性(HS)-CRP。次要结果指标包括炎症的其他生化指标,拟人指标和安全性评估。结果筛选了一百二十二(122)人作为研究对象,随机分配了44人,完成了研究的40人。在所有8个剂量组中,治疗8周后,HS-CRP的测定均较基线下降,而在安慰剂组中则上升。与安慰剂相比,18盎司组的基线变化不显着,但基线变化的比较显着(p = 0.02)。与安慰剂相比,其他炎症标志物(炎性细胞因子)和脂质过氧化标志物(F2异前列腺素)均未显示任何显着差异。果汁组的BMI呈下降趋势。在任何一组中均未报告有副作用,实验室或心电图安全性评估均未显示任何受试者的临床显着变化。结论在这项先导剂量研究中,与每天服用18 oz最高剂量的安慰剂相比,专有的山竹果汁混合物(XanGo Juice?)降低了CRP水平(与基线相比变化增加)。需要进一步的研究以确认并进一步确定这种果汁的益处。果汁被安全地服用。试用注册ISRCTN9300027

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