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

Primary Purpose

Glucose Metabolism Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deepure
Sponsored by
Tasly Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glucose Metabolism Disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NIS labsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Deepure Group A

Deepure Group B

Deepure Group C

Deepure Group D

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Post-prandial glucose response
Change in blood glucose leve after consuming test meal with and without Pu'er tea

Secondary Outcome Measures

Full Information

First Posted
July 26, 2018
Last Updated
October 29, 2018
Sponsor
Tasly Pharmaceuticals, Inc.
Collaborators
Natural Immune Systems Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03613688
Brief Title
Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Official Title
Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceuticals, Inc.
Collaborators
Natural Immune Systems Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deepure Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Deepure Group B
Arm Type
Experimental
Arm Description
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.
Arm Title
Deepure Group C
Arm Type
Experimental
Arm Description
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.
Arm Title
Deepure Group D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Deepure
Intervention Description
Pu'erh Tea extract
Primary Outcome Measure Information:
Title
Post-prandial glucose response
Description
Change in blood glucose leve after consuming test meal with and without Pu'er tea
Time Frame
From baseline to 30, 60, 90, 120, and 180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitte Jensen
Phone
(541) 884-0112
Email
gitte@nislabs.com
Facility Information:
Facility Name
NIS labs
City
Klamath Falls
State/Province
Oregon
ZIP/Postal Code
97601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitte Jensen
Phone
541-884-0112
Email
gitte@nislabs.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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