Blood CholesterolNCT03649620
Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
A study testing unripe Bokbunja Extract in people with Blood Cholesterol, run by Yonsei University.
Trial summary
This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Cholesterol
- What is being tested?
- unripe Bokbunja Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Feb 2018
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 20 and 65 years,
- Total cholesterol 200-239 mg/dl
- subjects giving written informed consent
Who cannot join
- Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction
- History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
- Participation in any other clinical trials within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- Pregnancy or breast feeding etc,.
About this study
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
This study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.
Read the detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.
- Conditions
- Blood Cholesterol
- Being tested
- unripe Bokbunja Extract, Placebo
- Keywords
- cholesterol, Bokbunja, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unripe Bokbunja ExtractDietary supplement
tablet(1 tablet/d, 600 mg/d) for 12 weeks
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| unripe Bokbunja Extract | Experimental | tablet(1 tablet/d, 600 mg/d) for 12 weeks Receives: Dietary Supplement: unripe Bokbunja Extract; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: unripe Bokbunja Extract; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Total cholesterol
Changes of total cholesterol were assessed before and after the intervention
Measured: 12 weeks
Secondary outcomes (4)
Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)
Changes of lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP) were assessed before and after the intervention
Measured: 12 weeks
Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1)
Changes of arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1) were assessed before and after the intervention
Measured: 12 weeks
Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)
Changes of anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass) were assessed before and after the intervention
Measured: 12 weeks
Changes of Oxidized LDL
Changes of oxidized LDL were assessed before and after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startDec 2016
- Primary completionMay 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood CholesterolStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649620
- Sponsor's protocol ID
- BC_cholesterol
- Status last verified
- May 2018
- First submitted
- 30 Jul 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Cho JM, Chae J, Jeong SR, Moon MJ, Ha KC, Kim S, Lee JH. The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial. Lipids Health Dis. 2020 Jul 9;19(1):166. doi: 10.1186/s12944-020-01338-z.
PubMed 32646501
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
- ClinicalTrials.gov ID
- NCT03649620
- Acronym / sponsor ID
- BC_cholesterol
- Conditions
- Blood Cholesterol
- Keywords
- cholesterol, Bokbunja, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 28 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 study was conducted to investigate the effects of daily supplementation of unripe Bokbunja extract on improvement of blood cholesterol.
Detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The investigators measured total cholesterol, lipid profile, arteriosclerosis index, anthropometric index, oxidized LDL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unripe Bokbunja Extract | Experimental | Dietary Supplement: unripe Bokbunja Extract, Dietary Supplement: Placebotablet(1 tablet/d, 600 mg/d) for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: unripe Bokbunja Extract, Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 20 and 65 years,
- Total cholesterol 200-239 mg/dl
- subjects giving written informed consent
Key exclusion criteria (5 listed)
- Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction
- History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
- Participation in any other clinical trials within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- Pregnancy or breast feeding etc,.
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 |
|---|---|---|
| unripe Bokbunja Extracttablet(1 tablet/d, 600 mg/d) for 12 weeks | Dietary supplement | Placebo, unripe Bokbunja Extract |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo, unripe Bokbunja Extract |
Primary outcome
Changes of Total cholesterol
Time frame: 12 weeks
Changes of total cholesterol were assessed before and after the intervention
4 secondary outcomes
Changes of Lipid profile(total cholesterol, LDL-cholesterol, triglyceride, HDL-cholesterol, free fatty acid, Apolipoprotein A1, Apolipoprotein B, Lipoprotein a, hs-CRP)
Time frame: 12 weeks
Changes of Arteriosclerosis index(total cholesterol/HDL-cholesterol, LDL-cholesterol/HDL-cholesterol, triglyceride/HDL-cholesterol, (total HDL-cholesterol-HDL-cholesterol)/HDL-cholesterol, Apolipoprotein B/Apolipoprotein A1)
Time frame: 12 weeks
Changes of Anthropometric index(weight, body mass index, waist hip ratio, waist, hip, fat percentage, lean body mass)
Time frame: 12 weeks
Changes of Oxidized LDL
Time frame: 12 weeks
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 28 Aug 2018.
- Derived from this study: PubMed 32646501Cho JM, Chae J, Jeong SR, Moon MJ, Ha KC, Kim S, Lee JH. The cholesterol-lowering effect of unripe Rubus coreanus is associated with decreased oxidized LDL and apolipoprotein B levels in subjects with borderline-high cholesterol levels: a randomized controlled trial. Lipids Health Dis. 2020 Jul 9;19(1):166. doi: 10.1186/s12944-020-01338-z.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing unripe Bokbunja Extract in people with Blood Cholesterol, run by Yonsei University.
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 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: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes of Total cholesterol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649620, which also lists 1 linked publication.
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 Aug 2018.