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

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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.

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.

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.
We found this trial at
1
site
Klamath Falls, Oregon 97601
Phone: 541-884-0112
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mi
from
Klamath Falls, OR
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