Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Post-prandial glucose response
研究概览
简要总结
This is a randomized, controlled, cross-over study on the effects of consumption of Deepure puerh tea extract (PTE) on glucose tolerance and metabolic markers.
详细描述
The study will involve consuming three different doses: 1 gram, 1.5 grams, and 2 grams, and will be given in warm water, with a bland meal. The effects on glucose and insulin after consumption will be evaluated.The subjects will be randomly assigned to one of four groups with different sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women;
- •Aged 18-70 years;
- •BMI between 20-30;
- •Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.
排除标准
- •Taking dietary supplements judged to interfere with the effects of Deepure on glucose metabolism (for example: cinnamon extract; chromium picolinate; mulberry extract; bitter melon extract, green tea extracts, black tea extracts, pu-erh tea);
- •Participation in other clinical trials, involving an investigational product or lifestyle change, during the last month;
- •Participation in another research study during this trial, involving an investigational product or lifestyle change; Taking prescription medication known to affect glucose metabolism;
- •Taking over-the-counter medication known to affect glucose metabolism;
- •Drinking 3 or more cups of tea daily;
- •Unwilling to abstain from drinking tea for 24 hours before clinic visits; (if a person drinks tea within 24 hours of a clinic visit, the person's visit will be re-scheduled);
- •Consuming 2 or more drinks of alcohol per day;
- •Unwilling to abstain from drinking alcohol for 10 hours before clinic visits;
- •Diagnosed with diabetes Type I; Taking medication for diabetes Type II;
- •Diagnosed with the thyroid disorder Hashimoto's disease;
- •Past major surgery to your stomach or intestines (minor surgery not a problem such as hernia repair, appendix removal, gallbladder removal);
- •Currently taking cholesterol-lowering medication (for example: statins);
- •Currently taking coumadin;
- •Major trauma within the past 6 months;
- •Major surgery within the past 6 months;
- •Severe chronic infectious disease (such as HIV, chronic hepatitis);
- •Active depression;
- •Self-reported eating disorders;
- •History of drug abuse during past two years;
- •Currently going through intense stressful events or life changes;
- •Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
- •Women of child-bearing potential: Not using effective contraception;
- •Food allergies or sensitivities to tea.
研究组 & 干预措施
Deepure Group A
Visit 3: Warm water without Deepure; Visit 4: Warm water with 1 g Deepure; Visit 5: Warm water with 1.5 g Deepure; Visit 6: Warm water with 2 g Deepure.
干预措施: Deepure (Dietary Supplement)
Deepure Group B
Visit 3: Warm water with 1 g Deepure; Visit 4: Warm water with 1.5 g Deepure; Visit 5: Warm water with 2 g Deepure; Visit 6: Warm water without Deepure.
干预措施: Deepure (Dietary Supplement)
Deepure Group C
Visit 3: Warm water with 1.5 g Deepure; Visit 4: Warm water with 2 g Deepure; Visit 5: Warm water without Deepure; Visit 6: Warm water with 1 g Deepure.
干预措施: Deepure (Dietary Supplement)
Deepure Group D
Visit 3: Warm water with 2 g Deepure; Visit 4: Warm water without Deepure; Visit 5: Warm water with 1 g Deepure; Visit 6: Warm water with 1.5 g Deepure.
干预措施: Deepure (Dietary Supplement)
结局指标
主要结局
Post-prandial glucose response
时间窗: From baseline to 30, 60, 90, 120, and 180 minutes
Change in blood glucose leve after consuming test meal with and without Pu'er tea
次要结局
未报告次要终点