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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Aalborg Universitetshospital; Aalborg University Hospital
• Treatments: Calcium polycarbophil; Psyllium

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