Effect of Beta-Glucan on Cholesterol Lowering

This study has been completed.
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Nancy Ames, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01408719
First received: August 2, 2011
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed. Our second aim is to investigate the mechanism responsible for the action, specifically, whether b- glucan lowers circulating cholesterol concentration via inhibiting cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet interactions are associated with cholesterol lowering by barley β-glucan.


Condition Intervention
Hypercholesterolemia
Dietary Supplement: Control
Dietary Supplement: 3g LMW beta-glucan
Dietary Supplement: 5g LMW beta-glucan
Dietary Supplement: 3g HMW beta-glucan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Changs in Total Cholesterol [ Time Frame: Beginning and end of each phase ] [ Designated as safety issue: No ]
    Fasted total cholesterol concentration will be measured using the automated enzymatic methods.

  • Changes in LDL Cholesterol [ Time Frame: Beginning and end of each phase ] [ Designated as safety issue: No ]
    Serum LDL cholesterol will be estimated using the Friedewald equation.


Secondary Outcome Measures:
  • Cholesterol Absorption/Synthesis [ Time Frame: End of each phase ] [ Designated as safety issue: No ]
    The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.

  • Potential Gene-nutrient Interactions: CYP7A1 and APOE [ Time Frame: Once for each participant ] [ Designated as safety issue: No ]
    The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.

  • Changes in Body Weight and Waist Circumference(WC) [ Time Frame: Every day for body weight; beginning and end of each phase for WC ] [ Designated as safety issue: No ]
    Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.


Enrollment: 45
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5g LMW beta glucan
5 gram low molecular weight barley beta-glucan diet for 35 days
Dietary Supplement: Control
Minimal beta-glucan
Experimental: 3g HMW beta glucan
3 gram high molecular weight barley beta-glucan diet for 35 days
Dietary Supplement: 3g LMW beta-glucan
3grams beta-glucan
Experimental: 3g LMW beta glucan
3 grams of low molecular weight beta-glucan diet for 35 days
Dietary Supplement: 5g LMW beta-glucan
5 grams beta-glucan
Placebo Comparator: Control
control diet containing negligible amount of beta glucan
Dietary Supplement: 3g HMW beta-glucan
3 grams of high molecular weight beta-glucan

Detailed Description:

This study consists of four dietary phases which are separated by >28 days wash-out period. During the treatment phase, participants will be provided with all meals for the 35 day period. Breakfast meals will be consumed under the supervision of the research staff and lunch, dinner and snacks will be provided to take home in take-out packaging. While subjects are on the wash-out period they will return to their normal diet. The meals are on a 7 day rotating schedule that reflect an average Canadian diet. Changes in blood lipids, body weight, and waist circumference will be measured during each treatment phase. Cholesterol absorption and synthesis will be examined by stable isotope method. Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 20-40 kg/m2
  • Fasting cholesterol levels of 5.0-8.0 mmol/L
  • Fasting serum LDL cholesterol levels of 2.7-5.0 mmol/L

Exclusion Criteria:

  • Pregnant or lactating
  • Taking lipid lowering medication or nutritional supplements that affect blood lipids
  • Dietary restrictions which would affect consuming the study diet for 5-wk for four study phases.
  • Not deemed healthy by study physician
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408719

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Neutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Agriculture and Agri-Food Canada
Investigators
Principal Investigator: Nancy Ames, PhD AAFC
  More Information

No publications provided

Responsible Party: Dr. Nancy Ames, Research Scientist & Adjunct Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01408719     History of Changes
Other Study ID Numbers: B2010:216
Study First Received: August 2, 2011
Results First Received: August 12, 2013
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Beta-Glucan
Barley
Molecular Weight
Viscosity
Cholesterol
Stable isotope
Gene-nutrient interaction

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

ClinicalTrials.gov processed this record on October 19, 2014