NL-OMON34622尚未招募不适用
Cholesterol Absorption Inhibition Study in humans after single intake of cholesterol lowering margarine, Unilever Study 09030-V, Study name: CASTELL - CASTE
nilever0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Apparently healthy males aged 20 - 65 y
- •- BMI 20-27 kg/m2
- •- LDL-C levels between 3.0 * 5.0 mmol/L, triglycerides < 3.0 mmol/L
- •- Non-smoker (tobacco, marijuana).
- •- No use of medication which interferes with study measurements
- •- Consumption <=< 21 alcoholic drinks in a typical week.
- •- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- •- No reported participation in night shift work during the study.
排除标准
- •- Unwilling to refrain from consumption of plant sterol or stanol containing products, e.g. Becel pro.activ, Benecol, etc one week before and during the study
- •- Plasma lipid profile which indicates deviating lipid / cholesterol homeostasis
- •- Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/ psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- •- Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit, including gallstones or biliary diseases.
- •- History of surgery related to the gastro-intestinal tract
- •- On a medically prescribed or weight reduction diet
- •- Recreational (intravenous) drug use.
- •- The use of psychotropic drugs, including: benzodiazepines or alcohol in excess of 21 units/ week for males
- •- Concomitant medication that may modulate gastro-intestinal secretions and pH (e.g. antacids, proton-pump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists)
- •- Concomitant medication that can alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgesics, adrenergic agents, calcium channel blockers)
- •- Concomitant medication that can alter intestinal transit (e.g. loperamide, chemical/ osmotic/bulk laxatives), or influence satiety/energy intake (e.g. sibutramine, glucocorticoids, anabolic steroids)
- •- Intolerance or allergy for test product.
研究者
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