Status:
COMPLETED
Long Term Effects of Plant Sterol and Stanol Esters
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
BACKGROUND Plant sterols and stanols are compounds that are structurally related to cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL cholesterol concentrations ...
Eligibility Criteria
Inclusion
- Statin-treatment
- Stable dietary habits
Exclusion
- Active cardiovascular disease like congestive heart failure or recent (\< 6 months) event (acute myocardial infarction, CVA)
- Impairment of renal function, as evidenced by increased serum creatinine \> 150 mcmol/L
- Hepatic diseases as manifested by ALT, AST, GGT, total bilirubin or ALP \> 2 times the upper limit of normal
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, and rheumatoid arthritis.
- Use of medication such as corticosteroids, diuretics or lipid lowering medication other than statins
- Unstable body weight (weight gain or loss \>3 kg in the past three months)
- Abnormal hematological profile
- Quetelet-index \> 32 kg/m2
- Diastolic blood pressure \> 100 mm Hg or systolic \> 160 mm Hg
- Abuse of drugs and/or alcohol
- Use of sterol or stanol ester products within the previous 30 days
- Participation in another study within 1 months prior to the screening visit
- Pregnant women or women with child-wish within the duration of the study
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00802516
Start Date
June 1 2003
End Date
June 1 2005
Last Update
October 12 2017
Active Locations (1)
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1
Maastricht University
Maastricht, Netherlands, 6229ER