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Trial record 34 of 54 for:    barley

Effect of Beta-Glucan on Cholesterol Lowering

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ClinicalTrials.gov Identifier: NCT01408719
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : March 11, 2014
Last Update Posted : November 5, 2015
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Nancy Ames, University of Manitoba

Tracking Information
First Submitted Date  ICMJE August 2, 2011
First Posted Date  ICMJE August 3, 2011
Results First Submitted Date  ICMJE August 12, 2013
Results First Posted Date  ICMJE March 11, 2014
Last Update Posted Date November 5, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
  • Changs in Total Cholesterol [ Time Frame: Beginning and end of each phase ]
    Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
  • Changes in LDL Cholesterol [ Time Frame: Beginning and end of each phase ]
    Serum LDL cholesterol will be estimated using the Friedewald equation.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Blood cholesterol [ Time Frame: 35 days ]
Total and LDL cholesterol lowering
Change History Complete list of historical versions of study NCT01408719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Cholesterol absorption and synthesis [ Time Frame: 35 days ]
Stable isotope experiment to measure cholesterol absorption and synthesis at the end of each study phase.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Beta-Glucan on Cholesterol Lowering
Official Title  ICMJE Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Control
    Minimal beta-glucan
  • Dietary Supplement: 3g LMW beta-glucan
    3grams beta-glucan
  • Dietary Supplement: 5g LMW beta-glucan
    5 grams beta-glucan
  • Dietary Supplement: 3g HMW beta-glucan
    3 grams of high molecular weight beta-glucan
Study Arms  ICMJE
  • Experimental: 5g LMW beta glucan
    5 gram low molecular weight barley beta-glucan diet for 35 days
    Intervention: Dietary Supplement: Control
  • Experimental: 3g HMW beta glucan
    3 gram high molecular weight barley beta-glucan diet for 35 days
    Intervention: Dietary Supplement: 3g LMW beta-glucan
  • Experimental: 3g LMW beta glucan
    3 grams of low molecular weight beta-glucan diet for 35 days
    Intervention: Dietary Supplement: 5g LMW beta-glucan
  • Placebo Comparator: Control
    control diet containing negligible amount of beta glucan
    Intervention: Dietary Supplement: 3g HMW beta-glucan
Publications * Wang Y, Harding SV, Eck P, Thandapilly SJ, Gamel TH, Abdel-Aal el-SM, Crow GH, Tosh SM, Jones PJ, Ames NP. High-Molecular-Weight β-Glucan Decreases Serum Cholesterol Differentially Based on the CYP7A1 rs3808607 Polymorphism in Mildly Hypercholesterolemic Adults. J Nutr. 2016 Apr;146(4):720-7. doi: 10.3945/jn.115.223206. Epub 2016 Mar 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2014)
45
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
37
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01408719
Other Study ID Numbers  ICMJE B2010:216
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Nancy Ames, University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Agriculture and Agri-Food Canada
Investigators  ICMJE
Principal Investigator: Nancy Ames, PhD AAFC
PRS Account University of Manitoba
Verification Date October 2015

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