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

NCT ID: NCT02221973

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-10-31

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.

Conditions

Primary Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

sterols and hawthorn powder

Intervention Type: DIETARY_SUPPLEMENT

there are two dose level of sterols (1.2g/d; 1/8g/d)

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

Group Type: EXPERIMENTAL

sterols and hawthorn powder

Intervention Type: DIETARY_SUPPLEMENT

there are two dose level of sterols (1.2g/d; 1/8g/d)

milk without sterols and hawthorn powder

Group Type: ACTIVE_COMPARATOR

sterols and hawthorn powder

Intervention Type: DIETARY_SUPPLEMENT

there are two dose level of sterols (1.2g/d; 1/8g/d)

Interventions

sterols and hawthorn powder

there are two dose level of sterols (1.2g/d; 1/8g/d)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anzhen Hospital, Capital University of Medical Sciences

Beijing, , China

Chao Yang 2nd Hospital

Beijing, , China

Chui Yang Liu Hospital

Beijing, , China

Countries

China

Other Identifiers

12.03.NRC

Identifier Type: -

Identifier Source: org_study_id