The Effect of Plant Sterol Supplement on Blood Cholesterol | NCT00485095

Studies
The Effect of Plant Sterol Supplement on Blood Cholesterol

NCT00485095

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jul 1, 2011Estimated

Enrollment

41Actual

Phase

Phase 4

Conditions

High Blood Cholesterol Level

Interventions

Intake of plant sterols

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 11, 2007

First Posted Date

Jun 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2011

Last Update Posted Date

Jul 1, 2011Estimated

Name	Class
Mills DA	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Name	Type	Description	Arm Group Labels	Other Names
Intake of plant sterols	Behavioral

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leiv Ose, MD	Lipidklinikken, Rikshospitalet-Radiumhospitalet HF	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lipidklinikken, Rikshospitalet Radiumhospitalet HF		Oslo			Norway
Rikshospitalet Radiumhospitalet HF, Oslo, Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23623012	Derived	Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstol 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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases