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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Milk fortified with plant sterol esters; Dietary Supplement: Plain milk

• Registration Number: NCT02475018
• Lead Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd

Brief 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.

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 Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Study First Posted: 2015-06-18
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk fortified with plant sterol esters	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.
Plain milk	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.

Primary Outcome Measures

Name	Time	Method
Change in Total Cholesterol(TC) during and after intervention	Baseline & 1 months & 2 mongths

Secondary Outcome Measures

Name	Time	Method
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
Change in Triglyceride(TG) during and after intervention	Baseline & 1 months & 2 mongths

Trial Locations

Locations (1)

BaiZhiFang Community Health Service Centre; 🇨🇳 Beijing, Beijing, China