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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-01-31

Brief Summary

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

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Detailed Description

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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

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Milk fortified with plant sterol esters

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

Plain milk

Intervention Type DIETARY_SUPPLEMENT

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.

No dairy product consumption

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No