Effects of combining a plant stanol enriched yogurt drink and a low dose statin on markers for inflammation and endothelial function and serum lipoprotein concentrations

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 132

Inclusion Criteria

1. Stable dietary habits
2. Men 55?70 years of age
3. Men 45?54 and women 55-70 years of age with at least one of the following criteria:
3.1. Familial history of coronary heart disease (CHD) in first degree relatives (parent/brother/sister). Only CHD in male relatives below 55 years and in female relatives below 65 years is considered.
3.2. Overweight as defined by body mass index (BMI) >25 (as calculated from weight and length) or abdominal obesity (waist circumference >102 cm for men, >88 cm for women)

Exclusion Criteria

1. Smoking
2. Active cardiovascular disease like congestive heart failure or recent (< 6 months) event (acute myocardial infarction, CVA)
3. Peripheral vascular disease
4. Familial hypercholesterolemia
5. Impairment of renal function, as evidenced by increased serum creatinine >150 mmol/l
6. Hepatic diseases as manifested by alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), total bilirubin or alkaline phosphatase (ALP) >2 times the upper limit of normal
7. Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease (COPD), inflammatory bowel diseases, and rheumatoid arthritis
8. Use of medication such as corticosteroids, diuretics or lipid lowering medication including statin use in the prior 2 months
9. Hypersensitivity to simvastatin or any excipient
10. Previous history of muscular toxicity with a statin or fibrate
11. Concomitant use of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, human immunodeficiency virus [HIV] protease inhibitors, erythromycin, clarithromycin, telithromycin, nefazodone)
12. Unstable body weight (weight gain or loss >3 kg in the past three months)
13. Abnormal hematological profile
14. Abuse of drugs and/or alcohol
15. Pregnant or breastfeeding women
16. Use of sterol or stanol ester products within the previous 30 days
17. Participation in another study within 1 month prior to the screening visit
18. Having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum lipid and lipoprotein concentrations.

Secondary Outcome Measures

Name	Time	Method
Serum markers for endothelial function and low grade systemic inflammation.

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