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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 November 2015
• Main ID: NCT02221973
• Date of registration: 19/08/2014
• Prospective Registration: No
• Primary sponsor: Nestlé
• Public title: Effect of a Low Fat Milk Product on Lipids Profile in Dyslipidemia Subjects Lipidown
• Scientific title: Effect of a Low Fat Milk Product on Serum Lipids Profile in Chinese Primary Dyslipidemia Subjects
• Date of first enrolment: July 2013
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02221973
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Dyslipidemia

Intervention(s)

Dietary Supplement: sterols and hawthorn powder

Primary Outcome(s)

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

Secondary Outcome(s)

predictive marker for cardiovascular disease [Time Frame: after 7 weeks of treatment]

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]

safety parameters [Time Frame: after 7 weeks of treatment]

phytosterol metabolism parameters [Time Frame: after 7 weeks of treatment]

biomarkers of lipid oxidation and inflammation [Time Frame: after 7 weeks of treatment]

Secondary ID(s)

12.03.NRC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors