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

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03613688
• Other study ID #: 079-007
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: July 2019

Study information

• Verified date: October 2018
• Source: Tasly Pharmaceuticals, Inc.
• Contact: Gitte Jensen
• Phone: (541) 884-0112
• Email: gitte[@]nislabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Dietary Supplement:
• Deepure
Pu'erh Tea extract

Locations

Country	Name	City	State
United States	NIS labs	Klamath Falls	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Tasly Pharmaceuticals, Inc.	Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-prandial glucose response	Change in blood glucose leve after consuming test meal with and without Pu'er tea	From baseline to 30, 60, 90, 120, and 180 minutes