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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2007

Last Updated Date

June 30, 2011

Start Date ^ICMJE

January 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Primary: Reduction in blood cholesterol

Change History

Complete list of historical versions of study NCT00485095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Plant Sterol Supplement on Blood Cholesterol

Official Title ^ICMJE

A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

High Blood Cholesterol Level

Intervention ^ICMJE

Behavioral: Intake of plant sterols

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00485095

Other Study ID Numbers ^ICMJE

2.2006.3407

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Mills DA

Investigators ^ICMJE

Principal Investigator:

Leiv Ose, MD

Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Information Provided By

Oslo University Hospital

Verification Date

February 2009

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

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