Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
NCT ID: NCT03613688
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2018-09-20
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Deepure Group A
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.
Deepure
Pu'erh Tea extract
Deepure Group B
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.
Deepure
Pu'erh Tea extract
Deepure Group C
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.
Deepure
Pu'erh Tea extract
Deepure Group D
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.
Deepure
Pu'erh Tea extract
Interventions
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Deepure
Pu'erh Tea extract
Eligibility Criteria
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Inclusion Criteria
* Aged 18-70 years;
* BMI between 20-30;
* Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Natural Immune Systems Inc
OTHER
Tasly Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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NIS labs
Klamath Falls, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Gitte Jensen
Role: primary
Other Identifiers
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079-007
Identifier Type: -
Identifier Source: org_study_id