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

Last updated: October 29, 2018
Sponsor: Tasly Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Disorders

Treatment

N/A

Clinical Study ID

NCT03613688
079-007
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Taking dietary supplements judged to interfere with the effects of Deepure on glucosemetabolism (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 orlifestyle change, during the last month;

  • Participation in another research study during this trial, involving aninvestigational product or lifestyle change; Taking prescription medication known toaffect 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 persondrinks tea within 24 hours of a clinic visit, the person's visit will bere-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 ashernia 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 becomepregnant;

  • Women of child-bearing potential: Not using effective contraception;

  • Food allergies or sensitivities to tea.

Study Design

Total Participants: 28
Study Start date:
September 20, 2018
Estimated Completion Date:
July 31, 2019

Study 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.

Connect with a study center

  • NIS labs

    Klamath Falls, Oregon 97601
    United States

    Active - Recruiting

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