Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Not Applicable
- Conditions
- Glucose Metabolism Disorders
- Interventions
- Dietary Supplement: Deepure
- Registration Number
- NCT03613688
- Lead Sponsor
- Tasly Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Men and women;
- Aged 18-70 years;
- BMI between 20-30;
- Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Deepure Group B Deepure 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. Deepure Group C Deepure 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. Deepure Group D Deepure 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. Deepure Group A Deepure 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.
- Primary Outcome Measures
Name Time Method Post-prandial glucose response 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NIS labs
🇺🇸Klamath Falls, Oregon, United States