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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-glucan
Type: Dietary Supplement
Group Labels: 1

5g LMW beta glucan

Name: 3g LMW beta-glucan

Description: 3grams beta-glucan
Type: Dietary Supplement
Group Labels: 1

3g HMW beta glucan

Name: 5g LMW beta-glucan

Description: 5 grams beta-glucan
Type: Dietary Supplement
Group Labels: 1

3g LMW beta glucan

Name: 3g HMW beta-glucan

Description: 3 grams of high molecular weight beta-glucan
Type: Dietary Supplement
Group Labels: 1

Control


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 phase

Description: Serum LDL cholesterol will be estimated using the Friedewald equation.

Measure: Changes in LDL Cholesterol

Time: Beginning and end of each phase

Secondary 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 phase

Description: 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 participant

Description: 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 WC

Purpose: 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.



HPO Nodes


HPO: