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The Effect of Plant Sterol Supplement on Blood Cholesterol

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ClinicalTrials.gov Identifier: NCT00485095
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : July 1, 2011
Sponsor:
Collaborator:
Mills DA
Information provided by:
Oslo University Hospital

Brief Summary:
The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.

Condition or disease Intervention/treatment Phase
High Blood Cholesterol Level Behavioral: Intake of plant sterols Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol
Study Start Date : January 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women 18-80 years old
  • Total cholesterol: 4.5-7.5 mmol/l
  • Triglycerides at or below 4.0 mmol/l

Exclusion Criteria:

  • BMI at or above 35 kg/m2
  • Secondary hyperlipidemia, included diabetes
  • Hypertension (at og higher than 170/110)
  • Coronar, perifery or cerebral vascular disease last 3 months
  • Familial hypercholesterolemia
  • Change in dose of statins, oestrogen or contraceptives last 3 months
  • Taking drugs which are known to interfere with the plasma level of cholesterol
  • Chronic rheumatoid diseases or other diseases known to affect c-reactive protein
  • Pregnancy
  • Lactation
  • Planning to reduce weight
  • Taking plant sterols

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485095


Locations
Norway
Lipidklinikken, Rikshospitalet Radiumhospitalet HF
Oslo, Norway
Rikshospitalet Radiumhospitalet HF, Oslo, Norway
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Mills DA
Investigators
Principal Investigator: Leiv Ose, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00485095     History of Changes
Other Study ID Numbers: 2.2006.3407
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: February 2009

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases