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

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.

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Deepure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gitte Jensen; Phone Number: (541) 884-0112; Email: gitte@nislabs.com

Study Locations

• United States
  • Oregon
    • Klamath Falls, Oregon, United States, 97601
      • Recruiting
      • NIS Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Dietary supplement: Deepure; Pu'erh Tea extract
EXPERIMENTAL: 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.	Dietary supplement: Deepure; Pu'erh Tea extract
EXPERIMENTAL: 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.	Dietary supplement: Deepure; Pu'erh Tea extract
EXPERIMENTAL: 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.	Dietary supplement: Deepure; Pu'erh Tea extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tasly Pharmaceuticals, Inc.
• Collaborators: Natural Immune Systems Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2018
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (ACTUAL): August 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 079-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No