None listed
Conditions
Interventions
1. Control yogurt drink + placebo tablets
2. Control yogurt drink + simvastatin tablets (10 mg/day)
3. Plant stanol ester yogurt drink + placebo tablets
4. Plant stanol ester yogurt drink + simvastatin tablets (10 mg/day).
Sponsors
Mc Neil Consumer Nutritionals Europe. 3-8 Carburton Street London WIW 5AJ
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stable dietary habits; 2. Men 55 –70 years of age; 3. Men 45 –54 and women over 55 -70 years of age with at least one of the following criteria : a. 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; b. Overweight as defined by BMI >25 (as calculated from weight and length) or abdominal obesity (waist circumference >102 cm for men, >88 cm for women).
Exclusion criteria
Exclusion criteria: 1. Smoking; 2. Active cardiovascular disease like congestive heart failure or recent ( 150 mmol/L; 6. Hepatic diseases as manifested by ALT, AST, GGT, total billirubin or ALP > 2 times the upper limit of normal; 7. Severe medical conditions that might interfere with the study such as epilepsy, asthma, 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 (eg itraconazole, ketoconazole, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum lipid and lipoprotein concentrations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum markers for endothelial function and low grade systemic inflammation. | — |
Contacts
Public ContactJ. Plat
University Maastricht (UM), Nutrition and Toxicology Research Institute Maastricht (NUTRIM), Departments of Human Biology, P.O. Box 616
Outcome results
None listed