Cholesterol Metabolism in Heterozygous Phytosterolemia
This study has been completed.
Sponsor:
University of Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01102647
First received: April 7, 2010
Last updated: April 28, 2011
Last verified: April 2011
| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2010 | ||||
| Last Updated Date | April 28, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Decrease in plasma LDL-cholesterol [ Time Frame: 28 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. |
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| Change History | Complete list of historical versions of study NCT01102647 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE |
Increase plasma plant sterols [ Time Frame: 28 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 |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cholesterol Metabolism in Heterozygous Phytosterolemia | ||||
| Official Title ICMJE | Assessment of Cholesterol Metabolism in Heterozygous Phytosterolemia | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Cardiovascular Disease | ||||
| Intervention ICMJE | Dietary Supplement: phytosterol ester
1.6 g phytosterols/day for 29 days
Other Name: Phytocell Phytosterols, NPN#: 80012048 |
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| Study Arm (s) | Experimental: Phytosterol ester
Plant sterol compared with placebo
Intervention: Dietary Supplement: phytosterol ester |
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| Publications * | Myrie SB, Mymin D, Triggs-Raine B, Jones PJ. Serum lipids, plant sterols, and cholesterol kinetic responses to plant sterol supplementation in phytosterolemia heterozygotes and control individuals. Am J Clin Nutr. 2012 Apr;95(4):837-44. Epub 2012 Feb 29. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 26 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01102647 | ||||
| Other Study ID Numbers ICMJE | B2009:133 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Peter J Jones, University of Manitoba | ||||
| Study Sponsor ICMJE | University of Manitoba | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Manitoba | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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