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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Milk fortified with plant sterol esters

Plain milk

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Shuhua Milk, plant sterol esters, serum cholesterol, human

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

BaiZhiFang Community Health Service Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Milk fortified with plant sterol esters

Plain milk

No dairy product consumption

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change in Total Cholesterol(TC) during and after intervention

Secondary Outcome Measures

Change in Triglyceride(TG) during and after intervention

Change in LDL-C level during and after intervention

Change in HDL-C level during and after intervention

Full Information

NCT ID

NCT02475018

First Posted

June 16, 2015

Last Updated

June 16, 2015

Sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02475018

Brief Title

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

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inner Mongolia Yili Industrial Group Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

Shuhua Milk, plant sterol esters, serum cholesterol, human

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Milk fortified with plant sterol esters

Arm Type

Experimental

Arm Description

Arm Title

Plain milk

Arm Type

Placebo Comparator

Arm 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.

Arm Title

No dairy product consumption

Arm Type

No Intervention

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Milk fortified with plant sterol esters

Intervention 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Plain milk

Intervention 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.

Primary Outcome Measure Information:

Title

Change in Total Cholesterol(TC) during and after intervention

Time Frame

Baseline & 1 months & 2 mongths

Secondary Outcome Measure Information:

Title

Change in Triglyceride(TG) during and after intervention

Time Frame

Baseline & 1 months & 2 mongths

Title

Change in LDL-C level during and after intervention

Time Frame

Baseline & 1 months & 2 mongths

Title

Change in HDL-C level during and after intervention

Time Frame

Baseline & 1 months & 2 mongths

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ignatious Szeto, Ph.D

Organizational Affiliation

Inner Mongolia Yili Industrial Group Co., Ltd

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jing Zhu

Organizational Affiliation

Beijing Research Institute for Nutrition Resources

Official's Role

Principal Investigator

Facility Information:

Facility Name

BaiZhiFang Community Health Service Centre

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

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

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