Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Status: | Recruiting |
---|---|
Conditions: | Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/2/2018 |
Start Date: | September 20, 2018 |
End Date: | July 2019 |
Contact: | Gitte Jensen |
Email: | gitte@nislabs.com |
Phone: | (541) 884-0112 |
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.
puerh tea extract (PTE) on glucose tolerance and metabolic markers.
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.
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.
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.
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