Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Peter Jones, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01131832
First received: May 25, 2010
Last updated: July 16, 2014
Last verified: July 2014

May 25, 2010
July 16, 2014
September 2010
February 2012   (final data collection date for primary outcome measure)
  • Serum Lipids [ Time Frame: Baseline (Day 1,2) and Endpoint (Day 27,28) of each experimental phase ] [ Designated as safety issue: No ]
    Total Cholesterol, LDL-c, HDL-c, Triglycerides
  • Serum non-cholesterol sterols [ Time Frame: Baseline (Day 1,2) and Endpoint (Day 27,28) of each experimental phase ] [ Designated as safety issue: No ]
    Lathosterol,Lanosterol,Desmosterol,Sitosterol,Campesterol,Cholestanol,
  • Genotype via single nucleotide polymorphism analysis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    SNP genotyping in genes related to cholesterol metabolism
Same as current
Complete list of historical versions of study NCT01131832 on ClinicalTrials.gov Archive Site
Not Provided
Haplotype analysis [ Time Frame: baseline ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
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 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Hyperlipidemia
  • Dietary Supplement: Plant sterol
  • Dietary Supplement: Placebo
Experimental: Plant sterol
Plant sterol supplementation
Interventions:
  • Dietary Supplement: Plant sterol
  • Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • fasting serum LDL cholesterol >3.0 mmol/L
  • high or low lathosterol to cholesterol ratio

Exclusion Criteria:

  • smoking
  • use of lipid lowering therapy
  • documented cardiovascular/atherosclerotic disease
  • inflammatory disease
  • diabetes
  • uncontrolled hypertension
  • kidney disease
  • liver disease
  • other systemic diseases
  • cancer
  • chronic alcohol consumption (> 2 servings/day)
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01131832
B2007:073
Not Provided
Dr. Peter Jones, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: Peter J.H. Jones, PhD Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
University of Manitoba
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP