Clinical trial NCT01251991: Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia
Official title: Additive Cholesterol Lowering Effect by Concomitant Treatment With Psyllium Husks and Isolated Soy Protein in Addition to Heart-healthy Diet in Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in LDL cholesterol at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
Secondary outcomes:
measure: Change from baseline in total cholesterol at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in HDL cholesterol at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in triglycerides at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in fasting plasma glucose at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in body weight at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in apolipoprotein B at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in small, dense LDL cholesterol at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
measure: Change from baseline in high sensitive CRP at 6 weeks
timeFrame: 3rd and 4th visits at the investigational site
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: The Lipid Clinic, Aalborg Hospital
state: RN
Study officials:
affiliation: Lipidklinikken, Aalborg Hospital
name: Erik B. Schmidt, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: