Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Effect of Plant Sterol Supplement on Blood Cholesterol
This study is currently recruiting participants.
Verified by Rikshospitalet HF, May 2007
Sponsors and Collaborators: Rikshospitalet HF
Mills DA
Information provided by: Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00485095
  Purpose

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


Condition Intervention Phase
High Blood Cholesterol Level
Behavioral: Intake of plant sterols
Phase IV

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol Dietary Supplements
Drug Information available for: Cholest-5-en-3-ol (3beta)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:
  • Primary: Reduction in blood cholesterol

Study Start Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485095

Contacts
Contact: Leiv Ose, MD leiv.ose@rikshospitalet.no

Locations
Norway
Rikshospitalet Radiumhospitalet HF, Oslo, Norway Recruiting
Oslo, Norway
Contact: Leiv Ose, MD         leiv.ose@rikshospitalet.no    
Lipidklinikken, Rikshospitalet Radiumhospitalet HF Recruiting
Oslo, Norway
Contact: Leiv Ose, MD         leiv.ose@rikshospitalet.no    
Sponsors and Collaborators
Rikshospitalet HF
Mills DA
Investigators
Principal Investigator: Leiv Ose, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
  More Information

Study ID Numbers: 2.2006.3407
Study First Received: June 11, 2007
Last Updated: June 11, 2007
ClinicalTrials.gov Identifier: NCT00485095  
Health Authority: Norway: The National Commitees for Medical Research Ethics

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009