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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
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
 Dietary Supplement: Plant sterol
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Haplotype analysis [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plant sterol
Plant sterol supplementation
 Dietary Supplement: Plant sterol Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131832

Locations
United States, Maryland
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, Canada, R3T 6C5
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Peter J.H. Jones, PhD Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
  More Information

Additional Information:
Richardson Centre for Functional Foods and Nutraceuticals  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Peter Jones, Professor, Food Science and Human Nutritional Sciences, University of Manitoba
ClinicalTrials.gov Identifier: NCT01131832     History of Changes
Other Study ID Numbers: B2007:198
Study First Received: May 25, 2010
Last Updated: February 28, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Manitoba:
Cholesterol, Plant sterols, Non-response, SNPs,

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013