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Completed

NCT Number: NCT01251991

Cholesterol Lowering Treatment With Psyllium Husks and Isolated Soy Protein 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Lipid Clinic, Aalborg Hospital

Aalborg, RN, 9000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psyllium husks

Drug

Oral suspension, oral use, two daily dosages consisting of 5 grams each

Isolated soy protein

Dietary Supplement

Oral suspension, oral use, 30 grams once per day

Isolated Whey Protein

Dietary Supplement

Oral suspension, oral use, 30 grams once per day

Microcrystalline Cellulose

Other

Oral suspension, oral use, two daily dosages consisting of 5 grams each

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Acronym: ProFi

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2010
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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