Clinical trial NCT03613688: Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Official title: Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: Tasly Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Natural Immune Systems Inc
First posted: 2018-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-prandial glucose response
timeFrame: From baseline to 30, 60, 90, 120, and 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: NIS labs
state: Oregon
Study officials:
References: