HyperlipidemiaNCT03332641
Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.
A study testing Citron peel extract in people with Hyperlipidemia, run by Hanyang University at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Citron peel extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2017to 28 Sep 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-75 years with Total cholesterol 200-239 mg/dL
Who cannot join
- Lipid lowering agent within past 6 months
- Severe cardiovascular disease(Mvodardial infarction, stroke, etc)
- Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, ect)
- Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
- Diabetes mellitus
- Allergic or hypersensitive to any of the ingredients in the test products
Show all 13Show fewer
- History of disease that could interfere with the test products or impede their absorption
- Under antipsychotic drugs therapy within past 2 months
- History of alcohol or substance abuse
- Participation in any other clinical trials within past 2 months
- Laboratory test by show the following results
- Pregnancy or breast feeding
- Not Contraception(except: Surgery for female infertility)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Improvement of Blood Cholesterol
This study was conducted to investigate the effects of daily supplementation of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.
Read the detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Citron(Citrus Junos Siebold ex Tanaka) Peel Extract or a placebo group. Blood cholesterol profiles before and after the intervention.
- Conditions
- Hyperlipidemia
- Being tested
- Citron peel extract, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citron peel extractDietary supplement
Citron peel extract for 12 weeks
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Citron peel Extract | Experimental | Citron peel extract for 12 weeks Receives: Dietary Supplement: Citron peel extract |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Cholesterol
Changes of Cholesterol were assessed before and after the intervention
Measured: 12 weeks
Secondary outcomes (2)
Changes of Lipid profile
Changes of Lipid profile 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 posted6 Nov 2017
- Study start7 Jun 2017
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsoon Park, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332641
- Sponsor's protocol ID
- HYI-17-060-1
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. 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 Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Improvement of Blood Cholesterol
- ClinicalTrials.gov ID
- NCT03332641
- Acronym / sponsor ID
- HYI-17-060-1
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 6 Nov 2017 (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 Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.
Detailed description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Citron(Citrus Junos Siebold ex Tanaka) Peel Extract or a placebo group. Blood cholesterol profiles before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citron peel Extract | Experimental | Dietary Supplement: Citron peel extractCitron peel extract for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19-75 years with Total cholesterol 200-239 mg/dL
Key exclusion criteria (13 listed)
- Lipid lowering agent within past 6 months
- Severe cardiovascular disease(Mvodardial infarction, stroke, etc)
- Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, ect)
- Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
- Diabetes mellitus
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 |
|---|---|---|
| Citron peel extractCitron peel extract for 12 weeks | Dietary supplement | Citron peel Extract |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes of Cholesterol
Time frame: 12 weeks
Changes of Cholesterol were assessed before and after the intervention
2 secondary outcomes
Changes of Lipid profile
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 17 Nov 2017.
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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 Citron peel extract in people with Hyperlipidemia, run by Hanyang University 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 1 inclusion and 13 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 17 Nov 2017. 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. 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 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?
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 17 Nov 2017.