The Effect of Plant Sterol Supplement on Blood Cholesterol

This study has been completed.
Sponsor:
Collaborator:
Mills DA
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00485095
First received: June 11, 2007
Last updated: June 30, 2011
Last verified: February 2009

June 11, 2007
June 30, 2011
January 2007
July 2007   (final data collection date for primary outcome measure)
Not Provided
Primary: Reduction in blood cholesterol
Complete list of historical versions of study NCT00485095 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Effect of Plant Sterol Supplement on Blood Cholesterol
A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
High Blood Cholesterol Level
Behavioral: Intake of plant sterols
Not Provided
Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstøl K. Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial. Atherosclerosis. 2013 Jun;228(2):421-5. doi: 10.1016/j.atherosclerosis.2013.03.001. Epub 2013 Mar 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00485095
2.2006.3407
Not Provided
Not Provided
Oslo University Hospital
Mills DA
Principal Investigator: Leiv Ose, MD Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Oslo University Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP