Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein in Hypercholesterolemia (ProFi)
This study is currently recruiting participants.
Verified June 2011 by Aalborg Universityhospital
Sponsor:
Aalborg Universityhospital
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01251991
First received: December 1, 2010
Last updated: June 23, 2011
Last verified: June 2011
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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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251991
Contacts
| Contact: Anders Sørensen, BSc | 99326898 ext +45 | andso@rn.dk |
Locations
| Denmark | |
| Lipidklinikken, Aalborg Hospital | Recruiting |
| Aalborg, Nordjylland, Denmark, 9100 | |
| Contact: Anders Sørensen, BSc 99326898 ext +45 andso@rn.dk | |
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
| Principal Investigator: | Erik B. Schmidt, Professor, MD | Lipidklinikken, Aalborg Hospital |
More Information
No publications provided
| Responsible Party: | Anders Sørensen/Registered dietician, Lipidklinikken, Aalborg Hospital |
| ClinicalTrials.gov Identifier: | NCT01251991 History of Changes |
| Other Study ID Numbers: | 2010-022822-34 |
| Study First Received: | December 1, 2010 |
| Last Updated: | June 23, 2011 |
| 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 May 23, 2013