DRKS00006189已完成未知
Effect of a dietary supplement with red rice on LDL-cholesterol
eibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung0 个研究点目标入组 155 人开始时间: 2014年7月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •men and women at the age of 18-70 years
- •- LDL-C =160mg/dl and =220mg/dl
- •- proband's written agreement to investigation after oral and written education about study content, demands and risks
- •- proband's willingness to consume one tablets per day
- •- proband's willingness to follow the given recommendations concerning nutrition and physical acitvity
排除标准
- •LDL-Cholesterol <160mg/dl or =220mg/dl
- •TG = 220mg/dl
- •Body-Mass-Index (BMI) >35 kg/m2
- •Bloodpressure: >160mmHg systolic oder >100mmHg diastolic
- •severe chronic illness (manifest coronary heart disease, cancer)
- •insulin-dependent diabetes mellitus Typ I and II
- •severe kidney or liver diseases
- •chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome) chronic inflammatory bowel disease not: appendicitis, gallstone surgery
- •hormonelle Störungen, beispielsweise Morbus Cushing und nicht behandelte Hyperthyreose
- •Hormonal disorders, for example, Cushing's syndrome and untreated hyperthyroidism
- •Intake of a statin and/ or statin therapy in the last 3 months before the baseline examination
- •Intake of prescribed lipid-lowering agents, inculding fibrates, bile acid binders, ezetimibe, nicotinic acid
- •Upcoming conversion or change of dosage of following medications: corticosteroids (oral), contraceptives, hormone replacement therapy, thiazide diuretics, beta-blockers, antidiabetics
- •Hypersensitivity to lovastatin or against one of the components of the investigational product or placebo
- •Aktive Lebererkrankung oder persistierende Erhöhung der Serum-Transaminasen
- •Actibe liver disease or persistent elevations of serum transaminases
- •Cholestasis
- •Use of nutrient supplements wich exert an effect on LDL levels and other lipid parameters such as: supplements with alpha-linolenic acid (ALA), beta-glucans (such as oats), betaine, Ketosan, glucomannan, guar resins, hydropropylmethylcellulose (HPMC), linoleic acid, red rice products, oleic acid, pectins, plant sterols / stanols and their esters
- •Myopathy or unexplained mucle pain
- •insufficient/ no contraception
- •pregnancy/ lactation
- •addiction to alcohol and/or drugs
- •missing consent
- •refusing / reset of the consent
- •simultaneous participation at another clinical trial or participation within the last 30 days
- •planned changes in diet, intensive training (strenght or endurance) planned surgery in the next 3 months
研究者
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