Blood Glucose, HighNCT04850326
Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet
A study testing AP green tea extract in people with Blood Glucose, High, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, High
- What is being tested?
- AP green tea extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2020to 26 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 19 years or over
- BMI < 30 kg/m2
- Fasting glucose level > 100 mg/dL (who is not under medication)
- Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives
Who cannot join
- At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
- Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
- Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
- In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate
The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal.
- Conditions
- Blood Glucose, High
- Being tested
- AP green tea extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP green tea extractDietary supplement
single intake of AP green tea extract
| Study group | Role | What they receive |
|---|---|---|
| AP green tea extract | Experimental | Not described Receives: Dietary Supplement: AP green tea extract |
| No intervention control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Blood glucose level
Change of Blood glucose level before and after high-carbohydrate/high-fat meal
Measured: 0 - 300 minute
Change of Insulin level
Change of Insulin level before and after high-carbohydrate/high-fat meal
Measured: 0 - 300 minute
Change of Triglyceride level
Change of Triglyceride level before and after high-carbohydrate/high-fat meal
Measured: 0 - 300 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start24 Jul 2020
- Primary completion2 Jan 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose, HighStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850326
- Sponsor's protocol ID
- AP-R-2019-02
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate
- ClinicalTrials.gov ID
- NCT04850326
- Acronym / sponsor ID
- AP-R-2019-02
- Conditions
- Blood Glucose, High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 20 Apr 2021 (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.
The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP green tea extract | Experimental | Dietary Supplement: AP green tea extract |
| No intervention control | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 19 years or over
- BMI < 30 kg/m2
- Fasting glucose level > 100 mg/dL (who is not under medication)
- Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives
Key exclusion criteria (4 listed)
- At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
- Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
- Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
- In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
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 |
|---|---|---|
| AP green tea extractsingle intake of AP green tea extract | Dietary supplement | AP green tea extract |
Primary outcome
Change of Blood glucose level
Time frame: 0 - 300 minute
Change of Blood glucose level before and after high-carbohydrate/high-fat meal
Change of Insulin level
Time frame: 0 - 300 minute
Change of Insulin level before and after high-carbohydrate/high-fat meal
Change of Triglyceride level
Time frame: 0 - 300 minute
Change of Triglyceride level before and after high-carbohydrate/high-fat meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AP green tea extract in people with Blood Glucose, High, run by Amorepacific Corporation at 1 site 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 4 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: finished, as of the sponsor's last update on 16 Jun 2021. 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Blood glucose level (time frame: 0 - 300 minute). The study lists 3 primary outcomes in all. 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 16 Jun 2021.