CClinicalTrials.gg
Status unknownNCT03613688Updated Oct 31, 2018

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

An interventional study of Deepure in Glucose Metabolism Disorders, sponsored by Tasly Pharmaceuticals, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Tasly Pharmaceuticals, Inc. · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Glucose Metabolism Disorders
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's planned enrollment of 28 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Tasly Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementDeepure

    Pu'erh Tea extract

06

What researchers measure

Primary outcomes

  1. Post-prandial glucose response

    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

07

Study locations

1 of 1 sites recruiting
  • NIS labs
    Klamath Falls, Oregon 97601, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03613688
Lead sponsor
Tasly Pharmaceuticals, Inc.
Collaborators
Natural Immune Systems Inc
Responsible party
Sponsor
First posted
Aug 3, 2018
Start date
Sep 20, 2018
Primary completion
Jun 2019 (estimated)
Completion
Jul 2019 (estimated)
Last update
Oct 31, 2018

Study contacts

Gitte Jensen
Contact
gitte@nislabs.com
(541) 884-0112

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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