The Effect of Plant Sterol Supplement on Blood Cholesterol

June 30, 2011 updated by: Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Lipidklinikken, Rikshospitalet Radiumhospitalet HF
      • Oslo, Norway
        • Rikshospitalet Radiumhospitalet HF, Oslo, Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Mills DA

Investigators

  • Principal Investigator: Leiv Ose, MD, Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.2006.3407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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