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

• ClinicalTrials.gov Identifier: NCT01251991
• Recruitment Status: Completed
• First Posted: December 2, 2010
• Last Update Posted: January 29, 2014
• Sponsor: Aalborg University Hospital
• Information provided by (Responsible Party): Anders Sorensen, Aalborg University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Psyllium husks; Dietary Supplement: Isolated soy protein; Dietary Supplement: Isolated whey protein; Other: Microcrystalline cellulose	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: January 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in LDL cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
   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

Secondary Outcome Measures :

1. Change from baseline in total cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
2. Change from baseline in HDL cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
3. Change from baseline in triglycerides at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
4. Change from baseline in fasting plasma glucose at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
5. Change from baseline in body weight at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
6. Change from baseline in apolipoprotein B at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
7. Change from baseline in small, dense LDL cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]
8. Change from baseline in high sensitive CRP at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Denmark

The Lipid Clinic, Aalborg Hospital

Aalborg, RN, Denmark, 9000

Sponsors and Collaborators

Aalborg University Hospital

Investigators

• Principal Investigator: Erik B. Schmidt, Professor, MD; Lipidklinikken, Aalborg Hospital

More Information

• Responsible Party: Anders Sorensen, Clinical dietitian, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT01251991
• Other Study ID Numbers: 2010-022822-34
• First Posted: December 2, 2010
• Last Update Posted: January 29, 2014
• Last Verified: June 2011

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Psyllium; Calcium polycarbophil; Cathartics; Gastrointestinal Agents; Antidiarrheals