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

Overview

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.

Full Title of Study: “Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2014

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: milk with 1.2g/d sterols and 8g/d hawthorn powder
  • Experimental: milk with 1.8g/d sterols and 8g/d hawthorn powder
  • Active Comparator: milk without sterols and hawthorn powder

Clinical Trial Outcome Measures

Primary Measures

  • serum concentration of Total Cholesterol (TC),
    • Time Frame: after 7 weeks of treatment.

Secondary Measures

  • 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
  • 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
  • phytosterol metabolism parameters
    • Time Frame: after 7 weeks of treatment
    • phytosterol metabolism parameters in fecal samples
  • predictive marker for cardiovascular disease
    • Time Frame: after 7 weeks of treatment
    • assess predictive marker for cardiovascular disease by non-invasive vascular screening device
  • safety parameters
    • Time Frame: after 7 weeks of treatment
    • safety parameters

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Société des Produits Nestlé (SPN)
  • Provider of Information About this Clinical Study
    • Sponsor

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