ISRCTN21530271已完成不适用
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
utrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)0 个研究点目标入组 132 人开始时间: 2005年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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