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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Enrollment: 41
Study Start Date: January 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485095

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

No publications provided by Oslo University Hospital

Additional 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
Study First Received: June 11, 2007
Last Updated: June 30, 2011
Health Authority: Norway: The National Commitees for Medical Research Ethics

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

ClinicalTrials.gov processed this record on July 13, 2014