Status:
COMPLETED
Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Primary Dyslipidemia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 r...
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02221973
Start Date
July 1 2013
End Date
October 1 2014
Last Update
November 13 2015
Active Locations (3)
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1
Anzhen Hospital, Capital University of Medical Sciences
Beijing, China
2
Chao Yang 2nd Hospital
Beijing, China
3
Chui Yang Liu Hospital
Beijing, China