A Randomized, Double-blind Controlled Trial to Investigate the Effects of Nutrilite Glucose Health Herbal Drink on Prediabetes Persons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Changes in blood glucose level（fasten plasma glucose）
研究概览
简要总结
The goal of this two arms, randomized, double-blind controlled trial is to study whether Nutrilite herbal drink could ameliorate blood glucose level in prediabetes population.
100 eligible Participants aged 18-65 years will be enrolled in one center. Participants will be randomly assigned to two study groups, with 50 subjects in each group.Study subjects will be administrated with either the Nutrilite product or a placebo drink for two months (8 weeks). And up to three study visits will be made by the subject over a 2-month period intervention.
Researchers will compare two groups to see if consumption of Nutrilite herbal drink could significantly ameliorate blood glucose level at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, age 18-65 years.
- •Participants who meet the following diagnostic criteria based on the "Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)" and "Guiding Principles for Evaluation of Health Food Efficacy": fasting blood glucose levels of >5.6 and <7.0 mmol/L, and/or 2-hour postprandial blood glucose levels ≥7.8 and <11.1 mmol/L.
- •Participants agree not to take any dietary supplements or foods for blood glucose controlduring the study.
- •Participants understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.
排除标准
- •Participants diagnosed with type 1 diabetes mellitus.
- •Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients
- •Participants who developed diabetic ketosis, acidosis, and infection within the past 3 months.
- •Participants who participated in other clinical trials within the past 3 months.
- •Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial;
- •Participantes who are allergic to the test samples.
- •PI considers that volunteers cannot fully cooperate with the trial arrangement.
结局指标
主要结局
Changes in blood glucose level（fasten plasma glucose）
时间窗: baseline day 0, day 56
fasten plasma glucose
Changes in blood glucose level (2-hour postprandial blood glucose levels)
时间窗: baseline day 0, day 56
2-hour postprandial blood glucose levels
次要结局
- Changes in islet function (insulin level)(baseline day 0, day 56)
- Symptom observation(baseline day 0, day 56)
- changes of glycated hemoglobin(baseline day 0, day 56)
- changes in islet function (C-peptide level)(baseline day 0, day 56)
- Changes in blood lipids profile (TC)(baseline day 0, day 56)
- Changes in blood lipids profile (TG)(baseline day 0, day 56)