Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia

Study Overview
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Brief Summary
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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.

Official Title
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Additive Cholesterol Lowering Effect by Concomitant Treatment With Psyllium Husks and Isolated Soy Protein in Addition to Heart-healthy Diet in Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Psyllium husks
* Dietary Supplement: Isolated soy protein
* Dietary Supplement: Isolated whey protein
* Other: Microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18,5 - 35 kg/m2 LDL cholesterol > 3,5 mmol/l Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combinatorial treatment<br> | Drug: Psyllium husks<br>* Oral suspension, oral use, two daily dosages consisting of 5 grams each<br>Dietary Supplement: Isolated soy protein<br>* Oral suspension, oral use, 30 grams once per day<br>|
| Active Comparator: Single treatment: Psyllium husks<br> | Drug: Psyllium husks<br>* Oral suspension, oral use, two daily dosages consisting of 5 grams each<br>Dietary Supplement: Isolated whey protein<br>* Oral suspension, oral use, 30 grams once per day<br>|
| Active Comparator: Single treatment: Isolated soy protein<br> | Dietary Supplement: Isolated soy protein<br>* Oral suspension, oral use, 30 grams once per day<br>Other: Microcrystalline cellulose<br>* Oral suspension, oral use, two daily dosages consisting of 5 grams each<br>|
| Placebo Comparator: Control<br> | Dietary Supplement: Isolated whey protein<br>* Oral suspension, oral use, 30 grams once per day<br>Other: Microcrystalline cellulose<br>* Oral suspension, oral use, two daily dosages consisting of 5 grams each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL cholesterol at 6 weeks | 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 | 3rd and 4th visits at the investigational site | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |