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

The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Milk fortified with plant sterol esters; Dietary supplement: Plain milk

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 Type: Interventional
• Enrollment (Actual): 179
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • BaiZhiFang Community Health Service Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
• Investigators: Study Director: Ignatious Szeto, Ph.D, Inner Mongolia Yili Industrial Group Co., Ltd; Principal Investigator: Jing Zhu, Beijing Research Institute for Nutrition Resources

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Estimate): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: human; serum cholesterol; Shuhua Milk; plant sterol esters
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: YL/CL-004