绿伯爵茶多酚胶囊人体试食试验的临床观察

Clinical observation of feeding trial of Green Earl Grey Tea polyphenol capsule in human volunteers

目的观察绿伯爵茶多酚胶囊的辅助降血脂保健功能及不良影响。方法将108例符合卫生部2003年版《保健食品检验与评价技术规范》标准的单纯血脂异常志愿受试者,随机分为试食组和安慰剂组,n=54例,分别服用绿伯爵茶多酚胶囊及安慰剂共45d,每次2粒,每日2次。观察血、尿、便生化指标变化,进行胸透、心电图和B超等检查。观察期间保持原来生活和饮食习惯。结果试食组血清甘油三酯和总胆固醇明显降低,实验前后自身比较及与安慰剂组比较,差异均有统计学意义(P<0.05,P<0.01);试食后高密度脂蛋白、胆固醇无明显降低,与安慰剂组比较差异无统计学意义(P>0.05)。2组的血红蛋白、红细胞、白细胞、谷丙转氨酶、谷草转氨酶、尿素氮、肌酐、总蛋白、白蛋白、血糖各项指标实验前后均在正常值范围内;试食前后尿、便常规检查均未见异常,胸透、心电图、腹部B超检查亦均未见异常;实验前后膳食结构无明显改变。结论绿伯爵茶多酚胶囊对受试者健康无不良影响,具有辅助降血脂的保健功能。

Objective To observe the hypolipidemic effects of Green Earl Grey Tea polyphenol capsule and its adverse effects.Methods We used the blind method and placebo control design.The simple abnormal lipids in 108 volunteers met the inclusion criteria.Based on the levels of serum lipid,the subjects were randomly divided into the trial group （54 cases） and the control group （54 cases）.The two groups were given Green Earl Grey Tea polyphenol capsules and placebo respectively for 45 days,2 capsules each time,2 times a day.Biochemical indicators such as the blood,urine and feces were observed; chest X-ray,electrocardiogram and abdominal B ultrasound examinations were carried out.The original life and dietary habits were kept during the period of observation.Results The subjects had serum glycerin with triglyceride and total cholesterol decreased significantly,before and after test and compared with the control group had significant difference （P＜ 0.05,P ＜ 0.01）.The subjects＇ high-density lipoprotein or cholesterol did not significantly reduce compared with the placebo group （P＞0.05）.In the subjects of group 2,hemoglobin,red blood cells,white blood cells,alanine aminotransferase,aspartate aminotransferase,blood urea nitrogen,creatinine,total protein,albumin,and blood sugar before and after test were all within the normal range.Before and after the feeding trial,the subjects＇ stool and urine routine examination results showed no abnormality; neither did chest X-ray,electrocardiogram,or abdominal B ultrasound examination results.The trial participants had no obvious change in dietary pattern before and after the test.Conclusion Green Earl Grey Tea polyphenol capsule has no adverse effects on the health of subjects but has the hypolipidemic function.