- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221973
Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects (Lipidown)
Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beijing, China
- Anzhen Hospital, Capital University of Medical Sciences
-
Beijing, China
- Chao Yang 2nd Hospital
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Beijing, China
- Chui Yang Liu Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: milk with 1.2g/d sterols and 8g/d hawthorn powder
|
there are two dose level of sterols (1.2g/d; 1/8g/d)
|
Experimental: milk with 1.8g/d sterols and 8g/d hawthorn powder
|
there are two dose level of sterols (1.2g/d; 1/8g/d)
|
Active Comparator: milk without sterols and hawthorn powder
|
there are two dose level of sterols (1.2g/d; 1/8g/d)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum concentration of Total Cholesterol (TC),
Time Frame: after 7 weeks of treatment.
|
after 7 weeks of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
other lipid and lipoprotein parameters in serum samples
|
at 4 and 7 weeks of treatment
|
biomarkers of lipid oxidation and inflammation
Time Frame: after 7 weeks of treatment
|
biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples
|
after 7 weeks of treatment
|
phytosterol metabolism parameters
Time Frame: after 7 weeks of treatment
|
phytosterol metabolism parameters in fecal samples
|
after 7 weeks of treatment
|
predictive marker for cardiovascular disease
Time Frame: after 7 weeks of treatment
|
assess predictive marker for cardiovascular disease by non-invasive vascular screening device
|
after 7 weeks of treatment
|
safety parameters
Time Frame: after 7 weeks of treatment
|
safety parameters
|
after 7 weeks of treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12.03.NRC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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