NCT03613688

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

July 26, 2018

Last Update Submit

October 29, 2018

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Deepure Group A

EXPERIMENTAL

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

Deepure Group B

EXPERIMENTAL

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

Deepure Group C

EXPERIMENTAL

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

Deepure Group D

EXPERIMENTAL

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

DeepureDIETARY_SUPPLEMENT

Pu'erh Tea extract

Deepure Group ADeepure Group BDeepure Group CDeepure Group D

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women;
  • Aged 18-70 years;
  • BMI between 20-30;
  • Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.

You may not qualify if:

  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIS labs

Klamath Falls, Oregon, 97601, United States

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Gitte Jensen

CONTACT

(541) 884-0112gitte@nislabs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 3, 2018

Study Start

September 20, 2018

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)