Blood SugarNCT06592365
Clinical Study to Evaluate the Effects and Safety of Green Tea Extract on Blood Glucose Regulation
A study testing GTE in people with Blood Sugar, run by Amorepacific Corporation at 3 sites in South Korea.
Trial summary
This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sugar
- What is being tested?
- GTE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 8 Aug 2022to 31 Dec 2024
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged between 19 to 64 years
- BMI between 18.5 and 29.9kg/m²
- fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
- subjects who voluntarily decide to participate in this study and sign the informed consent form.
Who cannot join
- Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
- Individuals diagnosed with diabetes and who have taken medications related to blood glucose
- Individuals congenital enzyme deficiencies related to sugar metabolism.
- with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
- Individuals ongoing treatment diseases significantly related glucose metabolism.
- Individuals with a history of surgery significantly related to glucose metabolism within the last 6 months
Show all 10Show fewer
- diagnosed with gastrointestinal diseases, cardiovascular diseases, uncontrolled chronic medical conditions, thyroid disorders, or active malignant tumors requiring medication
- Individuals with liver function impairment or acute or chronic hepatitis or liver cirrhosis
- Individuals with renal disorder
- Individuals with a weight change of 5 kg or more within the last 3 months.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 1 recruiting
- Recruiting
Kangbuk samsung hospital
Seoul
Jae-Heon Kang, jhkang100495@gmail.com
- Completed
Seoul National Universtiy Hospital
Seoul
- Completed
The Catholic University of Korea St. Vincent's Hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract(GTE) Consumption on Blood Glucose Regulation
This study was conducted to investigate the effects of green tea extracts on reducing blood glucose level
Read the detailed description
This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design
- Conditions
- Blood Sugar
- Being tested
- GTE, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTEDietary supplement
oral administration of GTE tablets once daily for 12 weeks
PlaceboDietary supplement
oral administration of placebo tablets once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| GTE (Green tea extract) | Active comparator | three tablets once daily Receives: Dietary Supplement: GTE |
| Placebo | Placebo comparator | three tablets once daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting glucose level
blood glucose level detection
Measured: Baseline, week 12
Secondary outcomes (4)
changes of indicator of lipid metabolism
Total cholesterol, HDL, LDL, TG
Measured: Baseline, week 12
OGTT
oral glucose tolerance test
Measured: Baseline, week 12
blood biomarkers
insulin etc.
Measured: Baseline, week 12
change in waist circumference(cm)
-waist circumference was measured using WHO guideline
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SugarStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Heon Kang, MD, PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592365
- Sponsor's protocol ID
- AP-R-2019-01
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effects and Safety of Green Tea Extract(GTE) Consumption on Blood Glucose Regulation
- ClinicalTrials.gov ID
- NCT06592365
- Acronym / sponsor ID
- AP-R-2019-01
- Conditions
- Blood Sugar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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 study was conducted to investigate the effects of green tea extracts on reducing blood glucose level
Detailed description
This study was conducted over 12 weeks with a randomized, double-blind, placebo-controlled, parellel design
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GTE (Green tea extract) | Active comparator | Dietary Supplement: GTEthree tablets once daily |
| Placebo | Placebo comparator | Dietary Supplement: Placebothree tablets once daily |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females aged between 19 to 64 years
- BMI between 18.5 and 29.9kg/m²
- fasting blood glucose between 100 and 139 mg/dL (Note: if some subjects with blood glucose range of 126 - 139 mg/dL, those who are taking or requre medication must be excluded to meet ethical standards.)
- subjects who voluntarily decide to participate in this study and sign the informed consent form.
Key exclusion criteria (10 listed)
- Individuals taking to obesity, dyslipidemia, or uncontrolled hypertension at the screening
- Individuals diagnosed with diabetes and who have taken medications related to blood glucose
- Individuals congenital enzyme deficiencies related to sugar metabolism.
- with hypersensitivity to the test food or ingredients(e.g., green tea, caffeine).
- Individuals ongoing treatment diseases significantly related glucose metabolism.
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 |
|---|---|---|
| GTEoral administration of GTE tablets once daily for 12 weeks | Dietary supplement | GTE (Green tea extract) |
| Placebooral administration of placebo tablets once daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change in fasting glucose level
Time frame: Baseline, week 12
blood glucose level detection
4 secondary outcomes
changes of indicator of lipid metabolism
Time frame: Baseline, week 12
OGTT
Time frame: Baseline, week 12
blood biomarkers
Time frame: Baseline, week 12
change in waist circumference(cm)
Time frame: Baseline, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Jae-Heon Kang, MD, PhD principal investigator
Kangbuk Samsung Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTE in people with Blood Sugar, run by Amorepacific Corporation at 3 sites in South Korea.
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 10 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 Jonghee Sohn, MS (800-555-5555, sohnjh@amorepacific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting glucose level (time frame: Baseline, week 12). 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 19 Sep 2024.