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

Aalborg University Hospital

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Psyllium husks; Dietary Supplement: Isolated whey protein; Other: Microcrystalline cellulose; Dietary Supplement: Isolated soy protein

Study type: Interventional

Funder types: Other

Identifiers

NCT01251991

2010-022822-34

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 4 patient groups, including a placebo group

Combinatorial treatment

Experimental group

Treatment:

Dietary Supplement: Isolated soy protein

Drug: Psyllium husks

Single treatment: Psyllium husks

Active Comparator group

Treatment:

Dietary Supplement: Isolated whey protein

Drug: Psyllium husks

Single treatment: Isolated soy protein

Active Comparator group

Treatment:

Other: Microcrystalline cellulose

Dietary Supplement: Isolated soy protein

Control

Placebo Comparator group

Treatment:

Other: Microcrystalline cellulose

Dietary Supplement: Isolated whey protein