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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00485095
Other study ID # 2.2006.3407
Secondary ID
Status Completed
Phase Phase 4
First received June 11, 2007
Last updated June 30, 2011
Start date January 2007
Est. completion date July 2007

Study information

Verified date February 2009
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: The National Commitees for Medical Research Ethics
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Intake of plant sterols


Locations

Country Name City State
Norway Lipidklinikken, Rikshospitalet Radiumhospitalet HF Oslo
Norway Rikshospitalet Radiumhospitalet HF, Oslo, Norway Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital Mills DA

Country where clinical trial is conducted

Norway,