Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: Isolated soy proteinDietary Supplement: Isolated whey proteinOther: Microcrystalline cellulose
- Registration Number
- NCT01251991
- Lead Sponsor
- Aalborg University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- BMI 18,5 - 35 kg/m2
- LDL cholesterol > 3,5 mmol/l
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Combinatorial treatment Psyllium husks - Combinatorial treatment Isolated soy protein - Single treatment: Psyllium husks Psyllium husks - Single treatment: Psyllium husks Isolated whey protein - Single treatment: Isolated soy protein Isolated soy protein - Single treatment: Isolated soy protein Microcrystalline cellulose - Control Isolated whey protein - Control Microcrystalline cellulose -
- Primary Outcome Measures
Name Time Method Change from baseline in LDL cholesterol at 6 weeks 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
- Secondary Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (1)
The Lipid Clinic, Aalborg Hospital
🇩🇰Aalborg, RN, Denmark