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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221973
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.

Condition or disease Intervention/treatment Phase
Primary Dyslipidemia Dietary Supplement: sterols and hawthorn powder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
Study Start Date : July 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: milk with 1.2g/d sterols and 8g/d hawthorn powder Dietary Supplement: sterols and hawthorn powder
there are two dose level of sterols (1.2g/d; 1/8g/d)

Experimental: milk with 1.8g/d sterols and 8g/d hawthorn powder Dietary Supplement: sterols and hawthorn powder
there are two dose level of sterols (1.2g/d; 1/8g/d)

Active Comparator: milk without sterols and hawthorn powder Dietary Supplement: sterols and hawthorn powder
there are two dose level of sterols (1.2g/d; 1/8g/d)




Primary Outcome Measures :
  1. serum concentration of Total Cholesterol (TC), [ Time Frame: after 7 weeks of treatment. ]

Secondary Outcome Measures :
  1. other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc. [ Time Frame: at 4 and 7 weeks of treatment ]
    other lipid and lipoprotein parameters in serum samples

  2. biomarkers of lipid oxidation and inflammation [ Time Frame: after 7 weeks of treatment ]
    biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples

  3. phytosterol metabolism parameters [ Time Frame: after 7 weeks of treatment ]
    phytosterol metabolism parameters in fecal samples

  4. predictive marker for cardiovascular disease [ Time Frame: after 7 weeks of treatment ]
    assess predictive marker for cardiovascular disease by non-invasive vascular screening device

  5. safety parameters [ Time Frame: after 7 weeks of treatment ]
    safety parameters



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221973


Locations
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China
Anzhen Hospital, Capital University of Medical Sciences
Beijing, China
Chao Yang 2nd Hospital
Beijing, China
Chui Yang Liu Hospital
Beijing, China
Sponsors and Collaborators
Nestlé
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02221973    
Other Study ID Numbers: 12.03.NRC
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: August 2014
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases