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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475018
• Other study ID #: YL/CL-004
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: June 16, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2014
• Source: Inner Mongolia Yili Industrial Group Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	BaiZhiFang Community Health Service Centre	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Inner Mongolia Yili Industrial Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Cholesterol(TC) during and after intervention		Baseline & 1 months & 2 mongths	No
Secondary	Change in Triglyceride(TG) during and after intervention		Baseline & 1 months & 2 mongths	No
Secondary	Change in LDL-C level during and after intervention		Baseline & 1 months & 2 mongths	No
Secondary	Change in HDL-C level during and after intervention		Baseline & 1 months & 2 mongths	No