LDL-cholesterol Level 130-159mg/dLNCT02779673
The Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level
A study testing Yoghurt drink containing plant stanol as esters and Yoghurt drink without plant stanol as esters in people with LDL-cholesterol Level 130-159mg/dL, run by Yonsei University.
Trial summary
The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- LDL-cholesterol Level 130-159mg/dL
- What is being tested?
- Yoghurt drink containing plant stanol as esters and Yoghurt drink without plant stanol as esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications)
Who cannot join
- taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs)
- history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
- history or presence of cancer
- history of a psychiatric disorder and/or drug or alcohol abuse or dependency;
- having a known intolerance to gluten or lactose
- having a known allergy to any ingredient in the investigational product
- women who are pregnant or desire to become pregnant during the study period or within 3 months of giving birth or breast feeding or within 3 months of cessation of breast feeding
- having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study
About this study
Official title: Investigation of the Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level in Korean Adult
The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.
Read the detailed description
The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.
- Conditions
- LDL-cholesterol Level 130-159mg/dL
- Being tested
- Yoghurt drink containing plant stanol as esters, Yoghurt drink without plant stanol as esters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoghurt drink containing plant stanol as estersOther
Yoghurt drink without plant stanol as estersOther
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Subjects randomized to the test group consumed yoghurt drink containing 3.4g plant stanol as ester for 1 per day for a period of 4 weeks. Receives: Other: Yoghurt drink containing plant stanol as esters |
| Placebo group | Placebo comparator | Subjects randomized to the placebo group consumed yoghurt drink without plant stanol as ester for 1 per day for a period of 4 weeks. Receives: Other: Yoghurt drink without plant stanol as esters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline LDL-cholesterol at 4-week
Measured: at baseline and 4-week follow-up
Change from baseline total cholesterol at 4-week
Measured: at baseline and 4-week follow-up
Change from baseline non-HDL-cholesterol at 4-week
Measured: at baseline and 4-week follow-up
Secondary outcomes (4)
Change from baseline triglyceride at 4-week
Measured: at baseline and 4-week follow-up
Change from baseline HDL-cholesterol at 4-week
Measured: at baseline and 4-week follow-up
Change from baseline Apolipoprotein A1 at 4-week
Measured: at baseline and 4-week follow-up
Change from baseline Apolipoprotein B at 4-week
Measured: at baseline and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LDL-cholesterol Level 130-159mg/dLStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779673
- Sponsor's protocol ID
- LF_cholesterol
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 23 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level in Korean Adult
- ClinicalTrials.gov ID
- NCT02779673
- Acronym / sponsor ID
- LF_cholesterol
- Conditions
- LDL-cholesterol Level 130-159mg/dL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 May 2016 (estimated)
- 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 purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.
Detailed description
The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Yoghurt drink containing plant stanol as estersSubjects randomized to the test group consumed yoghurt drink containing 3.4g plant stanol as ester for 1 per day for a period of 4 weeks. |
| Placebo group | Placebo comparator | Other: Yoghurt drink without plant stanol as estersSubjects randomized to the placebo group consumed yoghurt drink without plant stanol as ester for 1 per day for a period of 4 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications)
Key exclusion criteria (8 listed)
- taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs)
- history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
- history or presence of cancer
- history of a psychiatric disorder and/or drug or alcohol abuse or dependency;
- having a known intolerance to gluten or lactose
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 |
|---|---|---|
| Yoghurt drink containing plant stanol as esters | Other | Test group |
| Yoghurt drink without plant stanol as esters | Other | Placebo group |
Primary outcome
Change from baseline LDL-cholesterol at 4-week
Time frame: at baseline and 4-week follow-up
Change from baseline total cholesterol at 4-week
Time frame: at baseline and 4-week follow-up
Change from baseline non-HDL-cholesterol at 4-week
Time frame: at baseline and 4-week follow-up
4 secondary outcomes
Change from baseline triglyceride at 4-week
Time frame: at baseline and 4-week follow-up
Change from baseline HDL-cholesterol at 4-week
Time frame: at baseline and 4-week follow-up
Change from baseline Apolipoprotein A1 at 4-week
Time frame: at baseline and 4-week follow-up
Change from baseline Apolipoprotein B at 4-week
Time frame: at baseline and 4-week follow-up
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 23 May 2016.
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 Yoghurt drink containing plant stanol as esters and Yoghurt drink without plant stanol as esters in people with LDL-cholesterol Level 130-159mg/dL, 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 1 inclusion and 8 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 23 May 2016. 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?
Change from baseline LDL-cholesterol at 4-week (time frame: at baseline and 4-week follow-up). 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 23 May 2016.