CompletedPhase 2Phase 3ACTRN12605000303640
Dose response study of phytosterols in tablet dosage in adults with primary hypercholeterolemia
Randomised, four arm, double blind placebo controlled dose response study of phytosterols in tablet dosage in adults with primary hypercholesterolemia
Sponsor
Mayne Health Consumer Products
Enrollment
80 participants
Start Date
Jul 8, 2002
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss
Inclusion Criteria1
- LDL cholesterol greater then or equal to 3.5mmol/L and less than or equal to 5.7 mmol/L 2) Body mass index less than or equal to 32kg/m2
Exclusion Criteria1
- Triglyceride levels greater then 4mmol/L2) Total cholesterol greater than 10mmol/L3) Use of lipid lowering medications including herbal and other "natural" lipid lowering agents with one month of baseline4) Clinically abnormal liver function tests at baseline5) Pregnant or women unwilling to use birth control for the period of the study6) Diabetes7) Hypothyroidism8) Smokers9) Cardiovascular disease10) Subjects unwilling to comply with study protocol11) Poor venous access12) Any other condition which in the opinion of the investigators could compromise the study.
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Interventions
The study compared baseline levels of lipids with post-treatment lipid levels for placebo and three concentrations of phytosterols(900mg/day or 1800mg/day or 2700mg/day) following 12 weeks of treatmen
The study compared baseline levels of lipids with post-treatment lipid levels for placebo and three concentrations of phytosterols(900mg/day or 1800mg/day or 2700mg/day) following 12 weeks of treatment.
Locations(1)
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ACTRN12605000303640