Clinical trial NCT02475018: The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
Official title: The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Shuhua Milk
plant sterol esters
serum cholesterol
human
Lead sponsor: Inner Mongolia Yili Industrial Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-06-18
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total Cholesterol(TC) during and after intervention
timeFrame: Baseline & 1 months & 2 mongths
Secondary outcomes:
measure: Change in Triglyceride(TG) during and after intervention
timeFrame: Baseline & 1 months & 2 mongths
measure: Change in LDL-C level during and after intervention
timeFrame: Baseline & 1 months & 2 mongths
measure: Change in HDL-C level during and after intervention
timeFrame: Baseline & 1 months & 2 mongths
Other outcomes:
Locations:
city: Beijing
country: China
facility: BaiZhiFang Community Health Service Centre
state: Beijing
Study officials:
affiliation: Inner Mongolia Yili Industrial Group Co., Ltd
name: Ignatious Szeto, Ph.D
role: STUDY_DIRECTOR
affiliation: Beijing Research Institute for Nutrition Resources
name: Jing Zhu
role: PRINCIPAL_INVESTIGATOR
References: