Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Status unconfirmed · Not applicable
Conditions studied: Glucose Metabolism Disorders
In brief
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.
Key facts
- Study ID
- NCT03613688
- Run by
- Tasly Pharmaceuticals, Inc.
- People needed
- 28
- Starts
- 2018-09-20
- Expected to finish
- 2019-07-01
- Last updated by the study team
- 2018-10-31
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Men and women;
- Aged 18-70 years;
- BMI between 20-30;
- Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.
You may not qualify if…
- 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.
Where it is running
- NIS labs — Klamath Falls, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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