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Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects (Lipidown)

Primary Purpose

Primary Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sterols and hawthorn powder
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dyslipidemia

Eligibility Criteria

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

Inclusion Criteria:

  • Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC: 5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150- 500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.
  • Primary dyslipidemia.
  • The subject demonstrates an understanding of the given information and ability to record the requested data.
  • Having obtained his/her informed consent

Exclusion Criteria:

  • BMI above 32 kg/m2 ( morbid obesity).
  • Pregnant or lactating women or intent to get pregnant.
  • Menopause women on hormonal replacement therapy.
  • Familial hyperlipidemia.
  • Identified food allergy to dairy product or lactose intolerance.
  • Severe diseases in heart, liver, kidney or hematopoietic system before admission.
  • History of angina, myocardial infarction, coronary artery bypass, heart failure or other cardiovascular instability during the last 6 months.
  • History of diabetes, GI, renal, pulmonary, hepatic and biliary, hypothyroidism, mental disease no self-control capacity or no articulate.
  • Subject who are currently taking drugs that interfere with lipid profiles, including but not limited to statin, nicotinic acid, bile acid sequestrant, fibric acids, policosanol tablets.
  • Subject who has received any anti-hyperlipidemia medication in the past 4 weeks.
  • Subject who regularly takes supplements with the function of lipid reduction in the past 3 months or will take during the study (e.g. plant sterols, omega-3 fish oil, beta-glucan, nut-rich diet, soy protein, soluble oat fiber, red yeast rice or other cholesterol reducing functional ingredients).
  • In-patient hyperlipidemia subjects.
  • Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day.
  • Subject who cannot be expected to comply with the study procedures.
  • Subject who is currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Sites / Locations

  • Anzhen Hospital, Capital University of Medical Sciences
  • Chao Yang 2nd Hospital
  • Chui Yang Liu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

milk with 1.2g/d sterols and 8g/d hawthorn powder

milk with 1.8g/d sterols and 8g/d hawthorn powder

milk without sterols and hawthorn powder

Arm Description

Outcomes

Primary Outcome Measures

serum concentration of Total Cholesterol (TC),

Secondary Outcome Measures

other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.
other lipid and lipoprotein parameters in serum samples
biomarkers of lipid oxidation and inflammation
biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples
phytosterol metabolism parameters
phytosterol metabolism parameters in fecal samples
predictive marker for cardiovascular disease
assess predictive marker for cardiovascular disease by non-invasive vascular screening device
safety parameters
safety parameters

Full Information

First Posted
August 19, 2014
Last Updated
November 11, 2015
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02221973
Brief Title
Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
Acronym
Lipidown
Official Title
Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of LipiDown (Hawthorn + Phytosterol) clinical trial is to test the blood lipids reduction effect of plant sterols and hawthorn in milk powder in a pilot human trial: demonstrate potential to reduce total blood cholesterol more than 10% and/or total triglycerides more than 15%, as required by State food and drug administration (SFDA) regulation.
Detailed Description
The proposed clinical trial is a pilot randomized, double-blind, placebo controlled, parallel, multicenter study with three treatment groups. The total number of 75 subjects should be enrolled to provide for a 20% dropout rate. Subjects will be randomized into one of the following 3 groups: milk without sterols and hawthorn powder milk with 1.2g/d sterols and 8g/d hawthorn powder milk with 1.8g/d sterols and 8g/d hawthorn powder The trial population will consist of female or male volunteers aged 18 - 65 years of age with primary mild to moderate hyperlipidemia documented by a serum cholesterol of 5.18-6.21mmol/L AND serum Triglycerides (TG): 1.7-5.65mmol/L , for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
milk with 1.2g/d sterols and 8g/d hawthorn powder
Arm Type
Experimental
Arm Title
milk with 1.8g/d sterols and 8g/d hawthorn powder
Arm Type
Experimental
Arm Title
milk without sterols and hawthorn powder
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
sterols and hawthorn powder
Intervention Description
there are two dose level of sterols (1.2g/d; 1/8g/d)
Primary Outcome Measure Information:
Title
serum concentration of Total Cholesterol (TC),
Time Frame
after 7 weeks of treatment.
Secondary Outcome Measure Information:
Title
other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.
Description
other lipid and lipoprotein parameters in serum samples
Time Frame
at 4 and 7 weeks of treatment
Title
biomarkers of lipid oxidation and inflammation
Description
biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples
Time Frame
after 7 weeks of treatment
Title
phytosterol metabolism parameters
Description
phytosterol metabolism parameters in fecal samples
Time Frame
after 7 weeks of treatment
Title
predictive marker for cardiovascular disease
Description
assess predictive marker for cardiovascular disease by non-invasive vascular screening device
Time Frame
after 7 weeks of treatment
Title
safety parameters
Description
safety parameters
Time Frame
after 7 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese male or female 18 to 65 years old (inclusive). Fasting Serum TC: 5.18-6.21mmol/L (equals to 200-241 mg/dl) AND Serum TG: 1.7-5.65mmol/L (equals to 150- 500 mg/dl) for at least 1 time tested by central laboratory in the past 2 weeks prior to recruitment. Primary dyslipidemia. The subject demonstrates an understanding of the given information and ability to record the requested data. Having obtained his/her informed consent Exclusion Criteria: BMI above 32 kg/m2 ( morbid obesity). Pregnant or lactating women or intent to get pregnant. Menopause women on hormonal replacement therapy. Familial hyperlipidemia. Identified food allergy to dairy product or lactose intolerance. Severe diseases in heart, liver, kidney or hematopoietic system before admission. History of angina, myocardial infarction, coronary artery bypass, heart failure or other cardiovascular instability during the last 6 months. History of diabetes, GI, renal, pulmonary, hepatic and biliary, hypothyroidism, mental disease no self-control capacity or no articulate. Subject who are currently taking drugs that interfere with lipid profiles, including but not limited to statin, nicotinic acid, bile acid sequestrant, fibric acids, policosanol tablets. Subject who has received any anti-hyperlipidemia medication in the past 4 weeks. Subject who regularly takes supplements with the function of lipid reduction in the past 3 months or will take during the study (e.g. plant sterols, omega-3 fish oil, beta-glucan, nut-rich diet, soy protein, soluble oat fiber, red yeast rice or other cholesterol reducing functional ingredients). In-patient hyperlipidemia subjects. Alcohol > 3 glasses wine, or 2 beers, or 1 shot hard alcohol/day. Subject who cannot be expected to comply with the study procedures. Subject who is currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Facility Information:
Facility Name
Anzhen Hospital, Capital University of Medical Sciences
City
Beijing
Country
China
Facility Name
Chao Yang 2nd Hospital
City
Beijing
Country
China
Facility Name
Chui Yang Liu Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

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Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects

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