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临床试验/NCT04734132
NCT04734132已完成不适用

Effects of Moringa Oleifera Leaves on Glycemia, Lipemia and Inflammatory Profile. Nutritional Intervention Study in Prediabetic Patients

National Research Council, Spain2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Fasting Blood Glucose

研究概览

简要总结

Moringa oleifera (MO) is a traditional food in tropical and subtropical areas and has attained a growing interest for its medicinal properties. It's a nutrient-rich vegetable, high in protein and polyphenol content. The MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo.

详细描述

The tree Moringa oleifera (MO) is a traditional medicinal plant in tropical and subtropical areas, also consumed as food, which is currently expanding worldwide as a protein-rich leafy vegetable and for the medicinal value of its phytochemicals, in particular its glucosinolates. Specifically, MO dry leaves and leaf extracts have been shown to exert numerous in vitro activities and in vivo effects, including the hypoglycemic effect. Thus, MO could be an alternative to prevent or treat diabetes. In this sense, in vitro and preclinical experiments have shown that MO could potentially reverse some of the pathophysiological manifestation of diabetes and its comorbidities, such as hepatic fat accumulation and insulin resistance, oxidative stress, inflammation and peripheral hyperglycemia. Studies in humans, however, are still limited. This proposal aims to study the efficacy of Moringa oleifera to improve the control of glycaemia in subjects with prediabetes. A 3-month dietary intervention with MO dry leave capsules will be performed and compared to placebo. This will be a double-blind, randomized, placebo controlled, parallel group intervention study. Subjects will randomly consume either 6 capsules of dry MO leaves (400 mg dry leaf powder /capsule) or 6 placebo capsules per day during 3 months. The study subjects will provide samples for outcome measurements at three different time points: basal, 6 weeks and 12 weeks of supplementation. Glycaemia and plasma inflammatory and metabolic markers will be measured, as well as the gut microbiota composition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

One member of the research team was in charge of product preparation and delivery to the participants following the randomization list.

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prediabetes: HbA1c between 5.7-6.4 % or fasting blood glucose between 100 - 125 mg/dl or impaired glucose tolerance (> 140 mg/dl and < 200 mg/dl two hours post oral challenge).
  • No pharmacological treatment prescribed for glycemia control.

排除标准

  • Diabetes Mellitus
  • Impaired renal function: < 60% Glomerular filtration
  • Uncontrolled high blood pressure
  • Previous cardiovascular events or coronary disease
  • Autoimmune disease
  • Severe gastrointestinal disease
  • Psychiatric illness
  • Elevated liver enzymes (x2 normal range)
  • Alcohol abuse (higher than 14 and 21 doses/week for women and men, respectively)
  • Morbid obesity (BMI>35kg/m2)
  • Pregnancy
  • Pharmacological treatments that interfere with glucose control.

结局指标

主要结局

Fasting Blood Glucose

时间窗: 12 weeks

Measured in serum samples from fasting blood withdrawn in a Sodium Fluoride vacutainer tube

Glycated hemoglobin (HbA1C)

时间窗: 12 weeks

Measured in fasting serum

次要结局

  • Conversion rate from prediabetes to normal(12 weeks)

研究者

发起方
National Research Council, Spain
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Esther Nova Rebato

Principal Investigator

National Research Council, Spain

研究点 (2)

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