HypercholesterolemiaNCT02475018
The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
A study testing Milk fortified with plant sterol esters and Plain milk in people with Hypercholesterolemia, run by Inner Mongolia Yili Industrial Group Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Milk fortified with plant sterol esters and Plain milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jan 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18-65 yrs;
- Serum TC ≥5.18mmol/L, and TG≤2.25mmol/L;
- Normal blood pressure or able to control blood pressure within normal range;
- Willing to consent to study participation and to comply with study requirements.
Who cannot join
- Pregnant or breastfeeding women;
- Known allergies to dairy and any substance in the study product.For example lactose intolerance;
- Any comorbidity that could,in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes, including but not limited to cardiac disease, hepatic disease, renal disease, hematopoietic system disease and mental disease;
- Recent use (within 2 weeks of screening) of any prescription or OTC medication that affects serum total cholesterol or that may confound study outcomes.
Trial locations and contacts
1 site in 1 country.
China1 site
BaiZhiFang Community Health Service Centre
Beijing, Beijing Municipality, 100053
About this study
The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia.
Read the detailed description
In a randomized, placebo-controlled double-blind mono-centric study,179 subjects with total cholesterol (TC) level above 5.18mmol/L and triglyceride (TG) level lower than 2.25mmol/L were assigned to 500ml of low lactose milk enriched with 1.58g plant sterol esters or 500ml plain milk without plant sterols (placebo) or without any dairy product consumption (control) for 60 days. Subjects were instructed to maintain stable diet pattern and physical activity. Plasma concentrations of TC,TG,LDL cholesterol(LDL-C) and HDL cholesterol(HDL-C) were measured at initial visits, after 30days and after 60 days. The primary measurement was the change in TC. Secondary measurements were changes in TG,LDL-C and HDL-C.
- Conditions
- Hypercholesterolemia
- Being tested
- Milk fortified with plant sterol esters, Plain milk
- Keywords
- Shuhua Milk, plant sterol esters, serum cholesterol, human
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk fortified with plant sterol estersDietary supplement
250mL of Shuhua milk fortified with plant sterol esters(with plant sterol esters 262mg/100mL) has been taken twice per day. 500mL of Shuhua milk in total has been taken per day during the 60-days intervention.
Plain milkDietary supplement
250mL of placebo milk (plain milk) has been taken twice per day. 500mL of plain milk in total has been taken per day during the 60-days intervention.
| Study group | Role | What they receive |
|---|---|---|
| Milk fortified with plant sterol esters | Experimental | 250mL of Shuhua Milk fortified with plant sterol esters(with plant sterol esters 262mg/100mL) has been taken twice per day. 500mL of Shuhua milk in total has been taken per day during the 60-days intervention. Receives: Dietary Supplement: Milk fortified with plant sterol esters |
| Plain milk | Placebo comparator | 250mL of placebo milk(plain milk) has been taken twice per day. 500mL of plain milk in total has been taken per day during the 60-days intervention. Receives: Dietary Supplement: Plain milk |
| No dairy product consumption | No intervention | Participants have not consumed any dairy product during the 60-days of study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Cholesterol(TC) during and after intervention
Measured: Baseline & 1 months & 2 mongths
Secondary outcomes (3)
Change in Triglyceride(TG) during and after intervention
Measured: Baseline & 1 months & 2 mongths
Change in LDL-C level during and after intervention
Measured: Baseline & 1 months & 2 mongths
Change in HDL-C level during and after intervention
Measured: Baseline & 1 months & 2 mongths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionJan 2015
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inner Mongolia Yili Industrial Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignatious Szeto, Ph.D, Study director, Inner Mongolia Yili Industrial Group Co., LtdJing Zhu, Principal investigator, Beijing Research Institute for Nutrition Resources
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475018
- Sponsor's protocol ID
- YL/CL-004
- Status last verified
- Jul 2014
- First submitted
- 16 Jun 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
- ClinicalTrials.gov ID
- NCT02475018
- Acronym / sponsor ID
- YL/CL-004
- Conditions
- Hypercholesterolemia
- Keywords
- Shuhua Milk, plant sterol esters, serum cholesterol, human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Inner Mongolia Yili Industrial Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Jun 2015 (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 this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia.
Detailed description
In a randomized, placebo-controlled double-blind mono-centric study,179 subjects with total cholesterol (TC) level above 5.18mmol/L and triglyceride (TG) level lower than 2.25mmol/L were assigned to 500ml of low lactose milk enriched with 1.58g plant sterol esters or 500ml plain milk without plant sterols (placebo) or without any dairy product consumption (control) for 60 days. Subjects were instructed to maintain stable diet pattern and physical activity. Plasma concentrations of TC,TG,LDL cholesterol(LDL-C) and HDL cholesterol(HDL-C) were measured at initial visits, after 30days and after 60 days. The primary measurement was the change in TC. Secondary measurements were changes in TG,LDL-C and HDL-C.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Milk fortified with plant sterol esters | Experimental | Dietary Supplement: Milk fortified with plant sterol esters250mL of Shuhua Milk fortified with plant sterol esters(with plant sterol esters 262mg/100mL) has been taken twice per day. 500mL of Shuhua milk in total has been taken per day during the 60-days intervention. |
| Plain milk | Placebo comparator | Dietary Supplement: Plain milk250mL of placebo milk(plain milk) has been taken twice per day. 500mL of plain milk in total has been taken per day during the 60-days intervention. |
| No dairy product consumption | No intervention | –Participants have not consumed any dairy product during the 60-days of study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, 18-65 yrs;
- Serum TC ≥5.18mmol/L, and TG≤2.25mmol/L;
- Normal blood pressure or able to control blood pressure within normal range;
- Willing to consent to study participation and to comply with study requirements.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women;
- Known allergies to dairy and any substance in the study product.For example lactose intolerance;
- Any comorbidity that could,in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes, including but not limited to cardiac disease, hepatic disease, renal disease, hematopoietic system disease and mental disease;
- Recent use (within 2 weeks of screening) of any prescription or OTC medication that affects serum total cholesterol or that may confound study outcomes.
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 |
|---|---|---|
| Milk fortified with plant sterol esters250mL of Shuhua milk fortified with plant sterol esters(with plant sterol esters 262mg/100mL) has been taken twice per day. 500mL of Shuhua milk in total has been taken per day during the 60-days intervention. | Dietary supplement | Milk fortified with plant sterol esters |
| Plain milk250mL of placebo milk (plain milk) has been taken twice per day. 500mL of plain milk in total has been taken per day during the 60-days intervention. | Dietary supplement | Plain milk |
Primary outcome
Change in Total Cholesterol(TC) during and after intervention
Time frame: Baseline & 1 months & 2 mongths
3 secondary outcomes
Change in Triglyceride(TG) during and after intervention
Time frame: Baseline & 1 months & 2 mongths
Change in LDL-C level during and after intervention
Time frame: Baseline & 1 months & 2 mongths
Change in HDL-C level during and after intervention
Time frame: Baseline & 1 months & 2 mongths
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 18 Jun 2015.
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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.
Ignatious Szeto, Ph.D study director
Inner Mongolia Yili Industrial Group Co., Ltd
Jing Zhu principal investigator
Beijing Research Institute for Nutrition Resources
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk fortified with plant sterol esters and Plain milk in people with Hypercholesterolemia, run by Inner Mongolia Yili Industrial Group Co., Ltd at 1 site in China.
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 4 inclusion and 4 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 18 Jun 2015. 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 China. 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 Total Cholesterol(TC) during and after intervention (time frame: Baseline & 1 months & 2 mongths). 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 18 Jun 2015.