Glucose Metabolism DisordersNCT03613688
Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
A study testing Deepure in people with Glucose Metabolism Disorders, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Deepure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women;
- Aged 18-70 years;
- BMI between 20-30;
- Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NIS labs
Klamath Falls, Oregon, 97601
Gitte Jensen, 541-884-0112, gitte@nislabs.com
About this study
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.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Deepure
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepureDietary supplement
Pu'erh Tea extract
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Deepure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glucose response
Change in blood glucose leve after consuming test meal with and without Pu'er tea
Measured: From baseline to 30, 60, 90, 120, and 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start20 Sep 2018
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Natural Immune Systems Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613688
- Sponsor's protocol ID
- 079-007
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control
- ClinicalTrials.gov ID
- NCT03613688
- Acronym / sponsor ID
- 079-007
- Conditions
- Glucose Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Natural Immune Systems Inc
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Deepure Group A | Experimental | Dietary Supplement: DeepureVisit 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. |
| Deepure Group B | Experimental | Dietary Supplement: DeepureVisit 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. |
| Deepure Group C | Experimental | Dietary Supplement: DeepureVisit 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. |
| Deepure Group D | Experimental | Dietary Supplement: DeepureVisit 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women;
- Aged 18-70 years;
- BMI between 20-30;
- Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeepurePu'erh Tea extract | Dietary supplement | Deepure Group A, Deepure Group B, Deepure Group C, Deepure Group D |
Primary outcome
Post-prandial glucose response
Time frame: From baseline to 30, 60, 90, 120, and 180 minutes
Change in blood glucose leve after consuming test meal with and without Pu'er tea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deepure in people with Glucose Metabolism Disorders, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gitte Jensen ((541) 884-0112, gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial glucose response (time frame: From baseline to 30, 60, 90, 120, and 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.