The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Milk fortified with plant sterol esters
* Dietary Supplement: Plain milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk fortified with plant sterol esters<br>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. | Dietary Supplement: Milk fortified with plant sterol esters<br>* 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.<br>|
| Placebo Comparator: Plain milk<br>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. | Dietary Supplement: Plain milk<br>* 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.<br>|
| No Intervention: No dairy product consumption<br>Participants have not consumed any dairy product during the 60-days of study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Cholesterol(TC) during and after intervention |  | Baseline & 1 months & 2 mongths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Triglyceride(TG) during and after intervention |  | Baseline & 1 months & 2 mongths | 
| Change in LDL-C level during and after intervention |  | Baseline & 1 months & 2 mongths | 
| Change in HDL-C level during and after intervention |  | Baseline & 1 months & 2 mongths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shuhua Milk, plant sterol esters, serum cholesterol, human