NCT02221973

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	sterols and hawthorn powder	there are two dose level of sterols (1.2g/d; 1/8g/d)

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-08-21
• Last updated: 2015-11-13

Locations

3 sites across 1 country: China