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NCT01131832 · ClinicalTrials.gov registry record · Phase 4
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
A Phase 4 study, sponsored by University of Manitoba.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT01131832: Completed Phase 4 study, sponsored by University of Manitoba.
NCT01131832 is a Phase 4 study that has completed, run by University of Manitoba. The registered enrollment target is 71 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131832, a Phase 4 study, has completed, sponsored by University of Manitoba.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The substantial range of individual responsiveness to plant sterols has important ramifications. Marked differences across individuals in particular aspects of the cholesterol metabolic pathway must alter the impact of plant sterol consumption. As such, a pronounced need exists to understand the genetic and metabolic factors that explain the substantial degree of heterogeneity in response of lipid concentrations to plant sterols across individuals. The primary focus of this trial is to delineate the impact of differing cholesterol synthesis levels on response of LDL-C and other plasma lipids to plant sterol consumption. Participants pre-identified as high or low endogenous cholesterol synthesizers, according to their screening level of lathosterol to cholesterol ratios, will be given PS or a placebo containing margarine to consume under supervision for 4 weeks in a crossover design. The trial will characterize the responsiveness of the participants' total, LDL, and HDL cholesterol, as well as triacylglycerol (TG) concentrations, to plant sterol consumption. This research will determine if cholesterol synthesis phenotype predicts the responsiveness of lipids to plant sterol consumption. Variations in candidate genes involved in cholesterol metabolism will also be investigated in order to find associations with both cholesterol metabolism phenotypes and responsiveness of lipids to plant sterols. The output of this research will be to advance the knowledge of which genetic factors influence the degree of cardiovascular benefit derived from plant sterols through lipid lowering.
Primary Outcome
Total Cholesterol, LDL-C, HDL-C, Triglycerides
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Plant sterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01131832 record still lists
NCT01131832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01131832 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01131832 about?
NCT01131832 is a clinical study titled "Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols". The substantial range of individual responsiveness to plant sterols has important ramifications. Marked differences across individuals in particular aspects of the cholesterol metabolic pathway must alter the impact of plant sterol consumption. As such, a pronounced need exists to understand the gen...
What is the current status of trial NCT01131832?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2010-09. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01131832?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Plant sterol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01131832?
This trial is sponsored by University of Manitoba, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131832's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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