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

Inner Mongolia Yili Industrial Group

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Plain milk; Dietary Supplement: Milk fortified with plant sterol esters

Study type: Interventional

Funder types: Industry

Identifiers

NCT02475018

YL/CL-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 179 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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179 participants in 3 patient groups, including a placebo group

Milk fortified with plant sterol esters

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Milk fortified with plant sterol esters

Plain milk

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Plain milk

No dairy product consumption

No Intervention group

Description:

Participants have not consumed any dairy product during the 60-days of study period.