The Effect of Plant Sterol Supplement on Blood Cholesterol

NCT ID: NCT00485095

Last Updated: 2011-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-07-31

Brief Summary

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

Detailed Description

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Conditions

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High Blood Cholesterol Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Interventions

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Intake of plant sterols

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mills DA

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Leiv Ose, MD

Role: PRINCIPAL_INVESTIGATOR

Lipidklinikken, Rikshospitalet-Radiumhospitalet HF

Locations

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Lipidklinikken, Rikshospitalet Radiumhospitalet HF

Oslo, , Norway

Site Status

Rikshospitalet Radiumhospitalet HF, Oslo, Norway

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 23623012 (View on PubMed)

Other Identifiers

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2.2006.3407

Identifier Type: -

Identifier Source: org_study_id

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