Primary DyslipidemiaLipidownNCT02221973
Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
A study testing sterols and hawthorn powder in people with Primary Dyslipidemia, run by Société des Produits Nestlé (SPN) at 3 sites in China.
Trial summary
The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial: demonstrate potential to reduce total blood cholesterol more than 10% and/or total triglycerides more than 15%, as required by State food and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Dyslipidemia
- What is being tested?
- sterols and hawthorn powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2013to Oct 2014
- 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
- Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC: 5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150- 500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
- Primary dyslipidemia.
- The subject demonstrates an understanding of the given information and ability to record the requested data.
- Having obtained his/her informed consent
Who cannot join
- BMI above 32 kg/m2 ( morbid obesity).
- Pregnant or lactating women or intent to get pregnant.
- Menopause women on hormonal replacement therapy.
- Familial hyperlipidemia.
- Identified food allergy to dairy product or lactose intolerance.
- Severe diseases in heart, liver, kidney or hematopoietic system before admission.
Show all 15Show fewer
- History of angina, myocardial infarction, coronary artery bypass, heart failure or other cardiovascular instability during the last 6 months.
- History of diabetes, GI, renal, pulmonary, hepatic and biliary, hypothyroidism, mental disease no self-control capacity or no articulate.
- Subject who are currently taking drugs that interfere with lipid profiles, including but not limited to statin, nicotinic acid, bile acid sequestrant, fibric acids, policosanol tablets.
- Subject who has received any anti-hyperlipidemia medication in the past 4 weeks.
- Subject who regularly takes supplements with the function of lipid reduction in the past 3 months or will take during the study (e.g. plant sterols, omega-3 fish oil, beta-glucan, nut-rich diet, soy protein, soluble oat fiber, red yeast rice or other cholesterol reducing functional ingredients).
- In-patient hyperlipidemia subjects.
- Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day.
- Subject who cannot be expected to comply with the study procedures.
- Subject who is currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Anzhen Hospital, Capital University of Medical Sciences
Beijing
Chao Yang 2nd Hospital
Beijing
Chui Yang Liu Hospital
Beijing
About this study
Official title: Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial: demonstrate potential to reduce total blood cholesterol more than 10% and/or total triglycerides more than 15%, as required by State food and drug administration (SFDA) regulation.
Read the detailed description
The proposed clinical trial is a pilot randomized, double-blind, placebo controlled, parallel, multicenter study with three treatment groups.
The total number of 75 subjects should be enrolled to provide for a 20% dropout rate.
Subjects will be randomized into one of the following 3 groups:
- milk without sterols and hawthorn powder
- milk with 1.2g/d sterols and 8g/d hawthorn powder
- milk with 1.8g/d sterols and 8g/d hawthorn powder
The trial population will consist of female or male volunteers aged 18 - 65 years of age with primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
- Conditions
- Primary Dyslipidemia
- Being tested
- sterols and hawthorn powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterols and hawthorn powderDietary supplement
there are two dose level of sterols (1.2g/d; 1/8g/d)
| Study group | Role | What they receive |
|---|---|---|
| milk with 1.2g/d sterols and 8g/d hawthorn powder | Experimental | Not described Receives: Dietary Supplement: sterols and hawthorn powder |
| milk with 1.8g/d sterols and 8g/d hawthorn powder | Experimental | Not described Receives: Dietary Supplement: sterols and hawthorn powder |
| milk without sterols and hawthorn powder | Active comparator | Not described Receives: Dietary Supplement: sterols and hawthorn powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum concentration of Total Cholesterol (TC),
Measured: after 7 weeks of treatment.
Secondary outcomes (5)
other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.
other lipid and lipoprotein parameters in serum samples
Measured: at 4 and 7 weeks of treatment
biomarkers of lipid oxidation and inflammation
biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples
Measured: after 7 weeks of treatment
phytosterol metabolism parameters
phytosterol metabolism parameters in fecal samples
Measured: after 7 weeks of treatment
predictive marker for cardiovascular disease
assess predictive marker for cardiovascular disease by non-invasive vascular screening device
Measured: after 7 weeks of treatment
safety parameters
safety parameters
Measured: after 7 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221973
- Sponsor's protocol ID
- 12.03.NRC
- Acronym
- Lipidown
- Status last verified
- Aug 2014
- First submitted
- 19 Aug 2014
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
- ClinicalTrials.gov ID
- NCT02221973
- Acronym / sponsor ID
- Lipidown / 12.03.NRC
- Conditions
- Primary Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Aug 2014 (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 aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial: demonstrate potential to reduce total blood cholesterol more than 10% and/or total triglycerides more than 15%, as required by State food and drug administration (SFDA) regulation.
Detailed description
The proposed clinical trial is a pilot randomized, double-blind, placebo controlled, parallel, multicenter study with three treatment groups.
The total number of 75 subjects should be enrolled to provide for a 20% dropout rate.
Subjects will be randomized into one of the following 3 groups:
- milk without sterols and hawthorn powder
- milk with 1.2g/d sterols and 8g/d hawthorn powder
- milk with 1.8g/d sterols and 8g/d hawthorn powder
The trial population will consist of female or male volunteers aged 18 - 65 years of age with primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| milk with 1.2g/d sterols and 8g/d hawthorn powder | Experimental | Dietary Supplement: sterols and hawthorn powder |
| milk with 1.8g/d sterols and 8g/d hawthorn powder | Experimental | Dietary Supplement: sterols and hawthorn powder |
| milk without sterols and hawthorn powder | Active comparator | Dietary Supplement: sterols and hawthorn powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC: 5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150- 500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
- Primary dyslipidemia.
- The subject demonstrates an understanding of the given information and ability to record the requested data.
- Having obtained his/her informed consent
Key exclusion criteria (15 listed)
- BMI above 32 kg/m2 ( morbid obesity).
- Pregnant or lactating women or intent to get pregnant.
- Menopause women on hormonal replacement therapy.
- Familial hyperlipidemia.
- Identified food allergy to dairy product or lactose intolerance.
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 |
|---|---|---|
| sterols and hawthorn powderthere are two dose level of sterols (1.2g/d; 1/8g/d) | Dietary supplement | milk with 1.2g/d sterols and 8g/d hawthorn powder, milk with 1.8g/d sterols and 8g/d hawthorn powder, milk without sterols and hawthorn powder |
Primary outcome
serum concentration of Total Cholesterol (TC),
Time frame: after 7 weeks of treatment.
5 secondary outcomes
other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.
Time frame: at 4 and 7 weeks of treatment
biomarkers of lipid oxidation and inflammation
Time frame: after 7 weeks of treatment
phytosterol metabolism parameters
Time frame: after 7 weeks of treatment
predictive marker for cardiovascular disease
Time frame: after 7 weeks of treatment
safety parameters
Time frame: after 7 weeks of treatment
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 13 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sterols and hawthorn powder in people with Primary Dyslipidemia, run by Société des Produits Nestlé (SPN) at 3 sites 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 15 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 13 Nov 2015. 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 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. 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?
serum concentration of Total Cholesterol (TC), (time frame: after 7 weeks of treatment.). 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 13 Nov 2015.