Effect of Beta-Glucan on Cholesterol Lowering
- Conditions
- Hypercholesterolemia
- Interventions
- Dietary Supplement: 5g LMW beta-glucanDietary Supplement: 3g HMW beta-glucanDietary Supplement: ControlDietary 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
- 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
- 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
Group Intervention Description 3g LMW beta glucan 5g LMW beta-glucan 3 grams of low molecular weight beta-glucan diet for 35 days Control 3g HMW beta-glucan control diet containing negligible amount of beta glucan 5g LMW beta glucan Control 5 gram low molecular weight barley beta-glucan diet for 35 days 3g HMW beta glucan 3g LMW beta-glucan 3 gram high molecular weight barley beta-glucan diet for 35 days
- Primary Outcome Measures
Name Time Method Changs in Total Cholesterol Beginning and end of each phase Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Changes in LDL Cholesterol Beginning and end of each phase Serum LDL cholesterol will be estimated using the Friedewald equation.
- Secondary Outcome Measures
Name Time Method Cholesterol Absorption/Synthesis 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 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) 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