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

Hypercholesterolemia Clinical Trial

— ProFi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251991
• Other study ID #: 2010-022822-34
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2010
• Last updated: January 28, 2014
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: June 2011
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Lægemiddelstyrelsen
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	The Lipid Clinic, Aalborg Hospital	Aalborg	RN

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in total cholesterol at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in HDL cholesterol at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in triglycerides at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in fasting plasma glucose at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in body weight at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in apolipoprotein B at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in small, dense LDL cholesterol at 6 weeks		3rd and 4th visits at the investigational site	No
Secondary	Change from baseline in high sensitive CRP at 6 weeks		3rd and 4th visits at the investigational site	No