Investigation of Nutrilite Glucose Health Herbal Drink on Prediabetes Persons
2026年7月6日 更新者：Amway (China) R&D Center
A Randomized, Double-blind Controlled Trial to Investigate the Effects of Nutrilite Glucose Health Herbal Drink on Prediabetes Persons
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.
研究概览
研究类型
介入性
注册 (实际的)
117
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国
- Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂饮料
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1 sachet per time, 3 times a day after meal
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实验性的：nutrilite glucose health herbal drink
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1 sachet per time, 3 times a day after meal
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in blood glucose level（fasten plasma glucose）
大体时间：baseline day 0, day 56
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fasten plasma glucose
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baseline day 0, day 56
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Changes in blood glucose level (2-hour postprandial blood glucose levels)
大体时间：baseline day 0, day 56
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2-hour postprandial blood glucose levels
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baseline day 0, day 56
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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changes of glycated hemoglobin
大体时间：baseline day 0, day 56
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HbA1c level
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baseline day 0, day 56
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Changes in islet function (insulin level)
大体时间：baseline day 0, day 56
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insulin level
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baseline day 0, day 56
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changes in islet function (C-peptide level)
大体时间：baseline day 0, day 56
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C-peptide level
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baseline day 0, day 56
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Changes in blood lipids profile (TC)
大体时间：baseline day 0, day 56
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Total cholesterol
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baseline day 0, day 56
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Changes in blood lipids profile (TG)
大体时间：baseline day 0, day 56
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total triglycerides
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baseline day 0, day 56
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Symptom observation
大体时间：baseline day 0, day 56
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A clinical symptom scoring scale for abnormal glucose metabolism was formulated with reference to Internal Medicine of Traditional Chinese Medicine.
Symptoms were scored by mild, moderate and severe grades.
Total scores were recorded before and after the trial food administration to calculate the clinical symptom improvement rate.
The main observed clinical symptoms include excessive thirst with frequent drinking, polyphagia with easy hunger, frequent micturition and other related manifestations.
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baseline day 0, day 56
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年12月4日
初级完成 (实际的)
2026年4月30日
研究完成 (实际的)
2026年5月30日
研究注册日期
首次提交
2023年11月30日
首先提交符合 QC 标准的
2026年7月6日
首次发布 (实际的)
2026年7月8日
研究记录更新
最后更新发布 (实际的)
2026年7月8日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.