Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-07 @ 9:44 AM
Study NCT ID:
NCT02475018
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
Sponsor:
Inner Mongolia Yili Industrial Group Co., Ltd
Organization:
Study Overview
Official Title:
The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: