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

Primary Dyslipidemia Clinical Trial

— Lipidown  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02221973
• Other study ID #: 12.03.NRC
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: November 11, 2015
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Primary Dyslipidemia

Intervention

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

Locations

Country	Name	City	State
China	Anzhen Hospital, Capital University of Medical Sciences	Beijing
China	Chao Yang 2nd Hospital	Beijing
China	Chui Yang Liu Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum concentration of Total Cholesterol (TC),		after 7 weeks of treatment.	No
Secondary	other lipid and lipoprotein parameters in serum samples that could reveal cardiovascular disease (CVD) risk etc.	other lipid and lipoprotein parameters in serum samples	at 4 and 7 weeks of treatment	No
Secondary	biomarkers of lipid oxidation and inflammation	biomarkers of lipid oxidation and inflammation associated with atherogenesis in serum samples	after 7 weeks of treatment	No
Secondary	phytosterol metabolism parameters	phytosterol metabolism parameters in fecal samples	after 7 weeks of treatment	No
Secondary	predictive marker for cardiovascular disease	assess predictive marker for cardiovascular disease by non-invasive vascular screening device	after 7 weeks of treatment	No
Secondary	safety parameters	safety parameters	after 7 weeks of treatment	Yes