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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Psyllium husks; Dietary supplement: Isolated soy protein; Dietary supplement: Isolated whey protein; Other: Microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • RN
    • Aalborg, RN, Denmark, 9000
      • The Lipid Clinic, Aalborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Erik B. Schmidt, Professor, MD, Lipidklinikken, Aalborg Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 2, 2010

Study Record Updates

• Last Update Posted (Estimate): January 29, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Gastrointestinal Agents; Cathartics; Antidiarrheals; Psyllium; Calcium polycarbophil
• Other Study ID Numbers: 2010-022822-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No