Effect of milk fortified with plant sterols on the lipid profile of patients with moderate hypercholesterolemia

Completed

• Conditions: Dyslipidemia / Nutrition; Nutritional, Metabolic, Endocrine; Disorders of lipoprotein metabolism and other lipidaemias

• Registration Number: ISRCTN14285706
• Lead Sponsor: nilever R&D (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Men and women with moderate hypercholesterolemia
2. Aged between 18 and 75 years
3. Body mass index (BMI) <31 kg/m2
4. Serum total cholesterol between 4.91 and 7.75 mmol/L
5. Low Density Lipoprotein (LDL) cholesterol >3.36 mmol/L
6. Triglycerides <3.39 mmol/L
7. Participants can be under stable lipid-lowering drug treatment (statins or fibrates, statins at doses of no more than simvastatin 40 mg/day or equivalent) or cardiac medication in patients with previous cardiovascular disease
8. Written informed consent. Participants were given a leaflet with explanation of the study, including reasons for masking the contents of the milk product, and information on how to contact investigators if necessary.

Exclusion Criteria

1. Subjects on a weight-losing diet
2. Familial hypercholesterolemia
3. Established type 2 diabetes
4. Lactose intolerance
5. Consumption of products that can influence cholesterol metabolism (other than statins and fibrates), such as
5.1. resins
5.2. ezetimibe
5.3. psyllium products
5.4. fish oil products
5.5. soya lecithin
5.6 phytoestrogens

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Effects on the serum lipid profile <br>2. Effects on serum non-cholesterol sterol concentrations <br>2.1. demosterol <br>2.2. lathosterol<br>2.3. lanosterol<br>2.4. campesterol<br>2.5. sitosterol <br><br>Measurements are taken at baseline, after the run-in period, and at the end of the three 4-week diet intervention periods.

Secondary Outcome Measures

Name	Time	Method
Influence of baseline serum non-cholesterol concentrations and their on-treatment changes on the cholesterol-lowering response <br><br>Measurements are taken at the same time points than primary outcome measures.