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Effect of Beta-Glucan on Cholesterol Lowering

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408719
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : March 11, 2014
Last Update Posted : November 5, 2015
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Nancy Ames, University of Manitoba

Brief Summary:
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 β-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. In addition, we aim to investigate the alteration of the gut microbiota after β-glucan consumption and the correlation between the altered gut microbiota and cardiovascular disease risk factors.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Control Dietary Supplement: 3g LMW beta-glucan Dietary Supplement: 5g LMW beta-glucan Dietary Supplement: 3g HMW beta-glucan Not Applicable

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. Fecal samples will be collected at the end of each intervention phase and will be subjected to Illumina sequencing of 16S rRNA genes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
Study Start Date : November 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Changs in Total Cholesterol [ Time Frame: Beginning and end of each phase ]
    Fasted total cholesterol concentration will be measured using the automated enzymatic methods.

  2. Changes in LDL Cholesterol [ Time Frame: Beginning and end of each phase ]
    Serum LDL cholesterol will be estimated using the Friedewald equation.

Secondary Outcome Measures :
  1. Cholesterol Absorption/Synthesis [ Time Frame: End of each phase ]
    The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.

  2. Potential Gene-nutrient Interactions: CYP7A1 and APOE [ Time Frame: Once for each participant ]
    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.

  3. Changes in Body Weight and Waist Circumference(WC) [ Time Frame: Every day for body weight; beginning and end of each phase for WC ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408719

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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
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Principal Investigator: Nancy Ames, PhD AAFC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Nancy Ames, Research Scientist & Adjunct Professor, University of Manitoba Identifier: NCT01408719    
Other Study ID Numbers: B2010:216
First Posted: August 3, 2011    Key Record Dates
Results First Posted: March 11, 2014
Last Update Posted: November 5, 2015
Last Verified: October 2015
Keywords provided by Dr. Nancy Ames, University of Manitoba:
Molecular Weight
Stable isotope
Gene-nutrient interaction
Gut microbiota
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases