Cardiovascular Disease
Conditions
Brief summary
The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.
Detailed description
A plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout period will separate the two treatment periods. Plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium oxide, respectively.
Interventions
DIETARY_SUPPLEMENTphytosterol ester
1.6 g phytosterols/day for 29 days
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* heterozygous for phytosterolemia, wild-type.
Exclusion criteria
* Pregnant, * Previous heart attack, * Kidney disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in plasma LDL-cholesterol | 29 days | Other studies have found 10% reduction in plasma LDL-cholesterol after 2.2-3.2 gram of plant sterol supplementation for 4 weeks in heterozygous phytosterolemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase plasma plant sterols | 29 days | We will use a control group and compare the level of increase in plasma plant sterol levels in both group over the course of plant sterol consumption |
Countries
Canada
Outcome results
None listed