HypercholesterolemiaNCT06992765
Evaluation of Green Tea for Improving Blood Lipid Profile
A study testing Intervention in people with Hypercholesterolemia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The objects of this study are to evaluate the effects of the "Heysong japanese green tea" on the human subjects who are dyslipidemia. In this trial, 40 healthy subjects whose ages are 18~65 years old (20 for placebo and 20 for experimental) will be included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2023to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female. Age between 18-65 years old.
- Those who have been assessed as dyslipidemia by a family physician but have not yet required medication. The following measurement values were used as evaluation criteria:
- Hypercholesterolemia: plasma total cholesterol (TC) >200 mg/dL;
- Mixed hyperlipidemia: plasma total cholesterol (TC) >200 mg/dL , triglyceride (TG) >200 mg/dL;
- Hypertriglyceridemia: plasma triglyceride (TG) >200 mg/dL, and high-density lipoprotein cholesterol (HDL-C) < 35 mg/dL or TC/HDL-C >5.
Who cannot join
- Pregnant, breastfeeding, menopausal women.
- Take any drugs or supplements that can affect blood lipid levels 2 weeks before or during the experiment.
- People with intolerance to caffeine or green tea.
- People who take drugs for chronic diseases.
- People who smoke or drink alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Heysong Japanese Green Tea for Improving Blood Lipid Function
The objects of this study are to evaluate the effects of the "Heysong japanese green tea" on the human subjects who are dyslipidemia. In this trial, 40 healthy subjects whose ages are 18~65 years old (20 for placebo and 20 for experimental) will be included. The total experiment will be 16 weeks and the intervention period will be 12 weeks, within which, at wk 0, 2, 8, 14 and 16, serum triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) values would be measured. Urine/feces samples and anthropometric data will also be acquired. The results will be analyzed according to the methods published by the Ministry of Health and Welfare of Taiwan Food and Drug Administration.
- Conditions
- Hypercholesterolemia
- Being tested
- Intervention, Placebo
- Keywords
- Green tea, Cholesterol, Triglyceride, Blood lipid
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary supplement
2 bottles of light green tea daily containing totally 684 mg of catechin
PlaceboDietary supplement
2 bottles of light green tea daily containing totally 108 mg of catechin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 bottles of light green tea daily containing totally 108 mg of catechin Receives: Dietary Supplement: Placebo |
| Intervention | Experimental | 2 bottles of light green tea daily containing totally 684 mg of catechin Receives: Dietary Supplement: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum total cholesterol
Total cholesterol is measured by the Department of Laboratory Medicine of Taipei Medical University Hospital (TMUH)
Measured: Wk(-2), Week(0) (Baseline), Wk(6), Wk(12) and Wk(14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start15 Mar 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Eagletek Corp.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992765
- Sponsor's protocol ID
- lin5611_2
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Total cholesterol in serum
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heysong Japanese Green Tea for Improving Blood Lipid Function
- ClinicalTrials.gov ID
- NCT06992765
- Acronym / sponsor ID
- lin5611_2
- Conditions
- Hypercholesterolemia
- Keywords
- Green tea, Cholesterol, Triglyceride, Blood lipid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Eagletek Corp.
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 May 2025 (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 objects of this study are to evaluate the effects of the "Heysong japanese green tea" on the human subjects who are dyslipidemia. In this trial, 40 healthy subjects whose ages are 18~65 years old (20 for placebo and 20 for experimental) will be included. The total experiment will be 16 weeks and the intervention period will be 12 weeks, within which, at wk 0, 2, 8, 14 and 16, serum triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) values would be measured. Urine/feces samples and anthropometric data will also be acquired. The results will be analyzed according to the methods published by the Ministry of Health and Welfare of Taiwan Food and Drug Administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 bottles of light green tea daily containing totally 108 mg of catechin |
| Intervention | Experimental | Dietary Supplement: Intervention2 bottles of light green tea daily containing totally 684 mg of catechin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female. Age between 18-65 years old.
- Those who have been assessed as dyslipidemia by a family physician but have not yet required medication. The following measurement values were used as evaluation criteria:
Key exclusion criteria (5 listed)
- Pregnant, breastfeeding, menopausal women.
- Take any drugs or supplements that can affect blood lipid levels 2 weeks before or during the experiment.
- People with intolerance to caffeine or green tea.
- People who take drugs for chronic diseases.
- People who smoke or drink alcohol.
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 |
|---|---|---|
| Intervention2 bottles of light green tea daily containing totally 684 mg of catechin | Dietary supplement | Intervention |
| Placebo2 bottles of light green tea daily containing totally 108 mg of catechin | Dietary supplement | Placebo |
Primary outcome
Serum total cholesterol
Time frame: Wk(-2), Week(0) (Baseline), Wk(6), Wk(12) and Wk(14)
Total cholesterol is measured by the Department of Laboratory Medicine of Taipei Medical University Hospital (TMUH)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes. Total cholesterol in serum
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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 Intervention in people with Hypercholesterolemia, run by Taipei Medical University at 1 site in Taiwan.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Serum total cholesterol (time frame: Wk(-2), Week(0) (Baseline), Wk(6), Wk(12) and Wk(14)). 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 28 May 2025.