Background: There is no scientific evidence to support the beneficial effects of noni fruit juice which is claimed as a “natural health enhancer” and is consumed extensively.Aim: To evaluate the beneficial effects of noni fruit juice on glycaemic control, lipid profile and antioxidant activity and its safety in diabetic patients.Settings and Design: A hospital based, randomized, placebo-controlled, double-blind studyMaterial and Methods: 34 diabetic subjects with normal haematological, serum potassium, renal and liver function test and electrocardiogram readings were enrolled into the study. After collecting venous blood for biochemical efficacy measures, the subjects were randomly allocated to two treatment groups, either to receive noni juice or to get placebo, at a dose of 30 ml/day. The efficacy measures included fasting and postprandial blood glucose, complete lipid profile with fasting, serum fructosamine and endogenous antioxidants like super oxide dismutase and reduced glutathione. The safety and efficacy measures were repeated after 21 days of treatment with placebo or noni juice.Statistics: The baseline characteristics were compared between the groups using the unpaired t test. Pre-post treatment changes in the efficacy measures within each group and between the groups were analyzed by applying the repeated measures ANOVA test. P<0.05 was considered to be statistically significant. Results: The efficacy measures were comparable between the two groups at the entry into the study. The influence of the two treatments on blood glucose levels, on the lipid profile and on the endogenous antioxidant activity were similar, without statistical significance. The noni and placebo treated groups came out with decrease and increase in serum fructosamine levels, respectively, both changes being statistically insignificant. Between groups, the comparison of these changes appeared to be statistically significant (p=0.036). The safety measures were within the normal range and no adverse events were reported.Conclusion: Consumption of noni juice for 21 days yielded elusive results on glycaemic control. It’s beneficial effects on plasma lipid profile and endogenous antioxidant activity were not established. Consumption of the lowest recommended doses of noni fruit juice for a short period of 21 days was found to be safe in diabetic patients. Long term studies with a large population may be needed for evidence of the favourable effects of noni juice on organ functions.
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机译：背景：没有科学证据支持诺丽果汁被认为是“天然健康促进剂”并被广泛食用的有益效果。目的：评估诺丽果汁对血糖控制，脂质分布和抗氧化剂的有益作用设置和设计：基于医院的随机，安慰剂对照，双盲研究材料和方法：纳入34名血液学，血清钾，肾和肝功能检查及心电图正常的糖尿病受试者研究。在采集静脉血以进行生化功效测量后，将受试者随机分配至两个治疗组，分别接受诺丽汁或安慰剂治疗，剂量为30 ml /天。功效指标包括空腹和餐后血糖，空腹时完整的脂质分布，血清果糖胺和内源性抗氧化剂，如超氧化物歧化酶和还原型谷胱甘肽。使用安慰剂或诺丽果汁治疗21天后，重复进行安全性和有效性测量。统计：使用未配对t检验比较各组之间的基线特征。通过应用重复测量方差分析（ANOVA test），分析了治疗前后各组内以及各组之间疗效指标的变化。 P <0.05被认为具有统计学意义。结果：在进入研究阶段，两组之间的疗效指标相当。两种治疗对血糖水平，脂质分布和内源抗氧化活性的影响相似，但无统计学意义。诺丽和安慰剂治疗组的血清果糖胺水平分别降低和升高，两者变化在统计学上均无统计学意义。在各组之间，这些变化的比较似乎具有统计学意义（p = 0.036）。安全措施在正常范围内，没有不良反应的报道。结论：服用诺丽汁21天对血糖控制效果不明确。它对血浆脂质分布和内源性抗氧化活性的有益作用尚未建立。在糖尿病患者中，在21天的短时间内服用最低推荐剂量的诺丽果汁是安全的。为了证实诺丽果汁对器官功能的有利影响，可能需要进行大量人口的长期研究。
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