Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01408719
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2011-08-02
Brief Title:
Effect of Beta-Glucan on Cholesterol Lowering
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 manufacturers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None