NCT02475018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
Last Updated

June 18, 2015

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

June 16, 2015

Last Update Submit

June 16, 2015

Conditions

Hypercholesterolemia

Keywords

Shuhua Milkplant sterol estersserum cholesterolhuman

Outcome Measures

Primary Outcomes (1)

  • Change in Total Cholesterol(TC) during and after intervention

    Baseline & 1 months & 2 mongths

Secondary Outcomes (3)

  • Change in Triglyceride(TG) during and after intervention

    Baseline & 1 months & 2 mongths

  • Change in LDL-C level during and after intervention

    Baseline & 1 months & 2 mongths

  • Change in HDL-C level during and after intervention

    Baseline & 1 months & 2 mongths

Study Arms (3)

Milk fortified with plant sterol esters

EXPERIMENTAL

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: Milk fortified with plant sterol esters

Plain milk

PLACEBO COMPARATOR

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.

Dietary Supplement: Plain milk

No dairy product consumption

NO INTERVENTION

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

Interventions

Milk fortified with plant sterol estersDIETARY_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.

Milk fortified with plant sterol esters
Plain milkDIETARY_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.

Plain milk

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BaiZhiFang Community Health Service Centre

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ignatious Szeto, Ph.D

    Inner Mongolia Yili Industrial Group Co., Ltd

    STUDY DIRECTOR

  • Jing Zhu

    Beijing Research Institute for Nutrition Resources

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 18, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

June 18, 2015

Record last verified: 2014-07

Locations

CN(1)