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Report for Clinical Trial NCT01408719
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
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.
NCT01408719 Hypercholesterolemia MeSH: Hypercholesterolemia
HPO: Hypercholesterolemia
4 Interventions
Name: Control
Description: Minimal beta-glucanType: Dietary Supplement5g LMW beta glucan
Name: 3g LMW beta-glucan
Description: 3grams beta-glucanType: Dietary Supplement3g HMW beta glucan
Name: 5g LMW beta-glucan
Description: 5 grams beta-glucanType: Dietary Supplement3g LMW beta glucan
Name: 3g HMW beta-glucan
Description: 3 grams of high molecular weight beta-glucanType: Dietary SupplementControl
Primary Outcomes
Description: Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Measure: Changs in Total Cholesterol Time: Beginning and end of each phaseDescription: Serum LDL cholesterol will be estimated using the Friedewald equation.
Measure: Changes in LDL Cholesterol Time: Beginning and end of each phaseSecondary Outcomes
Description: The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.
Measure: Cholesterol Absorption/Synthesis Time: End of each phaseDescription: 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.
Measure: Potential Gene-nutrient Interactions: CYP7A1 and APOE Time: Once for each participantDescription: 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.
Measure: Changes in Body Weight and Waist Circumference(WC) Time: Every day for body weight; beginning and end of each phase for WCPurpose: Prevention
Allocation: Randomized
Crossover Assignment
There are 3 SNPs
SNPs
1 rs3808607
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).
Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol.
2 rs429358
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).
Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol.
3 rs7412
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).
Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol.