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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000303640

Enrollment

Registered

2005-09-06

Start date

2002-07-08

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 treatment.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1) 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 criteria

1) 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.

Outcome results