Oben Julius, Enonchong Ebangha, Kothari Shil, Chambliss Walter, Garrison Robert, Dolnick Deanne
Laboratory of Nutrition & Nutritional Biochemistry, Department of Biochemistry, University of Yaounde I, Cameroon.
Nutr J. 2008 May 20;7:16. doi: 10.1186/1475-2891-7-16.
The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee.
An 8-week, placebo-controlled, randomized, double-blind study was conducted with four groups, comparing the effects of NP 06-1 to placebo in overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or matching placebo was given in a dose of two capsules (370 mg each) twice daily. The outcome measures reported are lipid levels, weight, BMI, blood pressure and fasting glucose. Analyses of variance were used to compare changes of physiological measures over the trial period and between groups.
Eighty (80) subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. NP 06-1 administration was associated with a general improvement in lipid levels. Both the overweight and normal weight treatment groups had significant reductions in triglycerides and LDL-cholesterol, as well as a significant increase in HDL-cholesterol compared to their respective control groups. Overall there were decreases in blood pressure in both overweight and normal weight treatment groups compared to respective placebo groups. There was also a significant decrease in fasting glucose levels in the overweight treatment group compared to the start of the study and to the overweight placebo group. There was no change in fasting blood sugar for the normal weight groups. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their respective placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks, which was associated with a significant loss in BMI over time.
In this pilot study NP 06-1 had a beneficial effect on cardiovascular risk factors; namely lipid levels, blood pressure and fasting glucose levels. Administration of NP 06-1 was also associated with weight loss.
本临床研究的目的是评估膳食补充剂NP 06 - 1对被诊断为膝关节骨关节炎的超重和正常体重成年人心血管保护特性的潜在益处。
进行了一项为期8周的安慰剂对照、随机、双盲研究，分为四组，比较NP 06 - 1与安慰剂对被诊断为原发性膝关节骨关节炎的超重和正常体重受试者的影响。NP 06 - 1（两种植物提取物的组合；黄柏树皮和橙子皮）或匹配的安慰剂以每日两次、每次两粒胶囊（每粒370毫克）的剂量给药。报告的结果指标为血脂水平、体重、体重指数、血压和空腹血糖。方差分析用于比较试验期间及组间生理指标的变化。
招募了80名受试者，45名受试者完成了研究。未报告严重不良事件。服用NP 06 - 1与血脂水平的总体改善相关。与各自的对照组相比，超重和正常体重治疗组的甘油三酯和低密度脂蛋白胆固醇均显著降低，高密度脂蛋白胆固醇显著升高。总体而言，与各自的安慰剂组相比，超重和正常体重治疗组的血压均有所下降。与研究开始时及超重安慰剂组相比，超重治疗组的空腹血糖水平也显著降低。正常体重组的空腹血糖没有变化。与各自的安慰剂组相比，超重和正常体重治疗组均减轻了大量体重。超重治疗组在8周后平均体重减轻了5%，这与体重指数随时间的显著下降有关。
在这项初步研究中，NP 06 - 1对心血管危险因素具有有益作用；即血脂水平、血压和空腹血糖水平。服用NP 06 - 1还与体重减轻有关。
