Triglycerides HighNCT04850352
Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts
A study testing Heukcha Extracts in people with Triglycerides High, run by Amorepacific Corporation at 3 sites in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Triglycerides High
- What is being tested?
- Heukcha Extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 3 Apr 2019to 30 Apr 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
- Male and female subjects older than 19 years old
- Who has fasting blood triglyceride levels ≥ 150 mg/dL
- Who voluntarily agreed to participate in the study and signed an informed consent form
Who cannot join
- Those who are taking functional food designed for dyslipidemia reduction within 4 weeks before study participation
- Those who have been diagnosed and are on medication with dyslipidemia, cardiovascular disease, kidney disease, liver disease or thyroid disease within 4 weeks before study participation
- Fasting plasma glucose >126 mg/dL or treatment with medications including oral hypoglycemic agents or insulin
- Who has used or is expected to inevitably use prohibited concomitant medications during the study
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
- Who has dosed other study medications within 30 days before screening
- Who is determined ineligible for study participation by investigators for any other reasons
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
KangBuk Samsung Medical Center
Seoul, 03181
Seoul National University
Seoul
St. Vincent's Hospital, College of Medicine, The Catholic University of Korea
Suwon
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea(Heukcha) Extracts
This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.
Read the detailed description
This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.
- Conditions
- Triglycerides High
- Being tested
- Heukcha Extracts, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heukcha ExtractsDietary supplement
Experimental group: Heukcha Extracts
PlaceboDietary supplement
Placebo group
| Study group | Role | What they receive |
|---|---|---|
| Heukcha Extracts | Experimental | Take Heukcha Extracts capsule once daily for 8 weeks. Receives: Dietary Supplement: Heukcha Extracts |
| Placebo | Placebo comparator | Take placebo capsule once daily for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting triglycerides
Measured: Baseline, Week 4 and Week 8
Secondary outcomes (3)
Change in total cholesterol, LDL-C, HDL-C
Measured: Baseline, Week 4 and Week 8
Change in BMI (kg/m2)
Measured: Baseline, Week 4 and Week 8
Change in Waist circumference (cm)
Measured: Baseline, Week 4 and Week 8
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 start3 Apr 2019
- Primary completion3 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triglycerides 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belong Cho, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850352
- Sponsor's protocol ID
- AP-PV-2018-02
- Status last verified
- Jun 2021
- First submitted
- 14 Apr 2021
- Last updated
- 16 Jun 2021
- 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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea(Heukcha) Extracts
- ClinicalTrials.gov ID
- NCT04850352
- Acronym / sponsor ID
- AP-PV-2018-02
- Conditions
- Triglycerides High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 30 Apr 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.
This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.
Detailed description
This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heukcha Extracts | Experimental | Dietary Supplement: Heukcha ExtractsTake Heukcha Extracts capsule once daily for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake placebo capsule once daily for 8 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects older than 19 years old
- Who has fasting blood triglyceride levels ≥ 150 mg/dL
- Who voluntarily agreed to participate in the study and signed an informed consent form
Key exclusion criteria (7 listed)
- Those who are taking functional food designed for dyslipidemia reduction within 4 weeks before study participation
- Those who have been diagnosed and are on medication with dyslipidemia, cardiovascular disease, kidney disease, liver disease or thyroid disease within 4 weeks before study participation
- Fasting plasma glucose >126 mg/dL or treatment with medications including oral hypoglycemic agents or insulin
- Who has used or is expected to inevitably use prohibited concomitant medications during the study
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
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 |
|---|---|---|
| Heukcha ExtractsExperimental group: Heukcha Extracts | Dietary supplement | Heukcha Extracts |
| PlaceboPlacebo group | Dietary supplement | Placebo |
Primary outcome
Change in fasting triglycerides
Time frame: Baseline, Week 4 and Week 8
3 secondary outcomes
Change in total cholesterol, LDL-C, HDL-C
Time frame: Baseline, Week 4 and Week 8
Change in BMI (kg/m2)
Time frame: Baseline, Week 4 and Week 8
Change in Waist circumference (cm)
Time frame: Baseline, Week 4 and Week 8
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.
Belong Cho, MD, PhD principal investigator
Seoul National University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heukcha Extracts in people with Triglycerides High, 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 3 inclusion and 7 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 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?
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 in fasting triglycerides (time frame: Baseline, Week 4 and Week 8). 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; AzTrials last refreshed its copy on 30 Oct 2026.