Glucose Metabolism Disorders
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDeepure
Pu'erh Tea extract
Sponsors
Natural Immune Systems Inc
Tasly Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactGitte Jensen
Outcome results
None listed