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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: February 28, 2012
Last verified: February 2012
History of Changes

May 25, 2010
February 28, 2012
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
Haplotype analysis [ Time Frame: baseline ] [ Designated as safety issue: No ]
Same as current
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 present study's goal is to identify a genetic basis for variations in responsiveness to plant sterol use, and elucidate which components of control of cholesterol metabolism associate with the genetic factors identified. The long term target is to contribute to a growing database that will be used in conjunction with rapid genotyping assays to allow future practitioners to determine if plant sterol intervention will be an effective lipid-lowering therapy in at-risk patients. Specifically, it is hypothesized that haplotype frequencies for key lipid regulatory genes will associate with (i) plasma lipid and non cholesterol sterol (lathosterol) profiles, (ii) whole-body cholesterol absorption and synthesis and iii) the expression of cholesterol responsive genes in response to plant sterol consumption.
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
69
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
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01131832
B2007:198
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
February 2012

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