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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Sorensen, Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01251991
First received: December 1, 2010
Last updated: January 28, 2014
Last verified: June 2011
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: Psyllium husks
Dietary Supplement: Isolated soy protein
Dietary Supplement: Isolated whey protein
Other: Microcrystalline cellulose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Change from baseline in LDL cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in total cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in HDL cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in body weight at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in apolipoprotein B at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in small, dense LDL cholesterol at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]
  • Change from baseline in high sensitive CRP at 6 weeks [ Time Frame: 3rd and 4th visits at the investigational site ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251991

Locations
Denmark
The Lipid Clinic, Aalborg Hospital
Aalborg, RN, Denmark, 9000
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Principal Investigator: Erik B. Schmidt, Professor, MD Lipidklinikken, Aalborg Hospital
  More Information

No publications provided

Responsible Party: Anders Sorensen, Clinical dietitian, Aalborg Universityhospital
ClinicalTrials.gov Identifier: NCT01251991     History of Changes
Other Study ID Numbers: 2010-022822-34
Study First Received: December 1, 2010
Last Updated: January 28, 2014
Health Authority: Denmark: Lægemiddelstyrelsen

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals

ClinicalTrials.gov processed this record on September 18, 2014