Cholesterol Metabolism in Heterozygous Phytosterolemia
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Purpose
The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease |
Dietary Supplement: phytosterol ester |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia |
- Decrease in plasma LDL-cholesterol [ Time Frame: 29 days ] [ Designated as safety issue: No ]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.
- Increase plasma plant sterols [ Time Frame: 29 days ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 26 |
| Study Start Date: | April 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phytosterol ester
Plant sterol compared with placebo
|
Dietary Supplement: phytosterol ester
1.6 g phytosterols/day for 29 days
Other Name: Phytocell Phytosterols, NPN#: 80012048
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- heterozygous for phytosterolemia, wild-type.
Exclusion Criteria:
- Pregnant,
- Previous heart attack,
- Kidney disease.
Contacts and Locations More Information
No publications provided by University of Manitoba
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Peter J Jones, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01102647 History of Changes |
| Other Study ID Numbers: | B2009:133 |
| Study First Received: | April 7, 2010 |
| Last Updated: | April 28, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypercholesterolemia Intestinal Diseases Lipid Metabolism, Inborn Errors Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Gastrointestinal Diseases Digestive System Diseases Metabolism, Inborn Errors Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 18, 2013