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Effect of Beta-Glucan on Cholesterol Lowering

Not Applicable
Completed
Conditions
Hypercholesterolemia
Interventions
Dietary Supplement: 5g LMW beta-glucan
Dietary Supplement: 3g HMW beta-glucan
Dietary Supplement: Control
Dietary Supplement: 3g LMW beta-glucan
Registration Number
NCT01408719
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
3g LMW beta glucan5g LMW beta-glucan3 grams of low molecular weight beta-glucan diet for 35 days
Control3g HMW beta-glucancontrol diet containing negligible amount of beta glucan
5g LMW beta glucanControl5 gram low molecular weight barley beta-glucan diet for 35 days
3g HMW beta glucan3g LMW beta-glucan3 gram high molecular weight barley beta-glucan diet for 35 days
Primary Outcome Measures
NameTimeMethod
Changs in Total CholesterolBeginning and end of each phase

Fasted total cholesterol concentration will be measured using the automated enzymatic methods.

Changes in LDL CholesterolBeginning and end of each phase

Serum LDL cholesterol will be estimated using the Friedewald equation.

Secondary Outcome Measures
NameTimeMethod
Cholesterol Absorption/SynthesisEnd 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 APOEOnce 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)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.

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Neutraceuticals

🇨🇦

Winnipeg, Manitoba, Canada

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