Additive Cholesterol Lowering Effect by Concomitant Treatment With Psyllium Husks and Isolated Soy Protein in Addition to Heart-healthy Diet in Hypercholesterolemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from baseline in LDL cholesterol at 6 weeks
研究概览
简要总结
Despite improved treatment, cardiovascular disease remains one of the most common diseases and causes of death in the Western world. Hypercholesterolemia is a well known risk factor for developing cardiovascular disease. Prevention and treatment are based in part on lowering LDL cholesterol. Dietary and lifestyle changes always play an important part of the treatment and preventive effort, and conversion to a heart-healthy diet reduces LDL cholesterol by a mean 10%. Further lowering of LDL cholesterol by means of food supplements have been demonstrated in numerous studies. Cholesterol lowering food supplements include isolated soy protein and water soluble dietary fibre such as psyllium husks. Postulated mechanisms of action responsible for the cholesterol lowering in these two food supplements are different, so there is a reason to expect an additive cholesterol lowering effect during concomitant treatment with both substances. The investigators want to investigate whether concomitant treatment with psyllium husks and isolated soy protein in addition to a heart-healthy diet results in a significantly greater reduction of LDL cholesterol in hypercholesterolemia, than single treatment with each of the substances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18,5 - 35 kg/m2
- •LDL cholesterol > 3,5 mmol/l
排除标准
- •Triglycerides > 5,0 mmol/l
- •Use of phytosterols, food supplements containing soy protein or water soluble fiber supplements
- •Cardiovascular disease
- •Diabetes mellitus
- •Gastrointestinal disease
- •Liver- og kidney disease
- •Electrolyte imbalance
- •Orlistat treatment
- •Alcohol abuse
- •Hypersensitivity to the interventional substances
- •Pregnancy and nursing
研究组 & 干预措施
Combinatorial treatment
干预措施: Psyllium husks (Drug)
Combinatorial treatment
干预措施: Isolated soy protein (Dietary Supplement)
Single treatment: Psyllium husks
干预措施: Psyllium husks (Drug)
Single treatment: Psyllium husks
干预措施: Isolated whey protein (Dietary Supplement)
Single treatment: Isolated soy protein
干预措施: Isolated soy protein (Dietary Supplement)
Single treatment: Isolated soy protein
干预措施: Microcrystalline cellulose (Other)
Control
干预措施: Isolated whey protein (Dietary Supplement)
Control
干预措施: Microcrystalline cellulose (Other)
结局指标
主要结局
Change from baseline in LDL cholesterol at 6 weeks
时间窗: 3rd and 4th visits at the investigational site
3rd and 4th visits equal the ends of the 1st and 2nd intervention period at +6 weeks and +16 weeks from baseline respectively (4 week wash-out period in between the intervention periods). 2nd visit includes randomization and baseline measurement, while 1st visit @ -4 weeks compared to baseline includes screening and inclusion
次要结局
- Change from baseline in apolipoprotein B at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in small, dense LDL cholesterol at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in high sensitive CRP at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in fasting plasma glucose at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in body weight at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in total cholesterol at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in HDL cholesterol at 6 weeks(3rd and 4th visits at the investigational site)
- Change from baseline in triglycerides at 6 weeks(3rd and 4th visits at the investigational site)
研究者
Anders Sorensen
Clinical dietitian
Aalborg University Hospital