Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control

Study Overview
=================
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.

Official Title
-----------------
Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control

Conditions
-----------------
Glucose Metabolism Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: Deepure


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deepure Group A<br>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. | Dietary Supplement: Deepure<br>* Pu'erh Tea extract<br>|
| Experimental: Deepure Group B<br>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. | Dietary Supplement: Deepure<br>* Pu'erh Tea extract<br>|
| Experimental: Deepure Group C<br>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. | Dietary Supplement: Deepure<br>* Pu'erh Tea extract<br>|
| Experimental: Deepure Group D<br>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. | Dietary Supplement: Deepure<br>* Pu'erh Tea extract<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial glucose response | Change in blood glucose leve after consuming test meal with and without Pu'er tea | From baseline to 30, 60, 90, 120, and 180 minutes |