NCT02475018

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2015-06-18
• Last updated: 2015-06-18

Locations

1 site across 1 country: China