Clinical trial NCT01408719: Effect of Beta-Glucan on Cholesterol Lowering
Official title: Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Beta-Glucan
Barley
Molecular Weight
Viscosity
Cholesterol
Stable isotope
Gene-nutrient interaction
Gut microbiota
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2011-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changs in Total Cholesterol
timeFrame: Beginning and end of each phase
measure: Changes in LDL Cholesterol
timeFrame: Beginning and end of each phase
Secondary outcomes:
measure: Cholesterol Absorption/Synthesis
timeFrame: End of each phase
measure: Potential Gene-nutrient Interactions: CYP7A1 and APOE
timeFrame: Once for each participant
measure: Changes in Body Weight and Waist Circumference(WC)
timeFrame: Every day for body weight; beginning and end of each phase for WC
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Neutraceuticals
state: Manitoba
Study officials:
affiliation: AAFC
name: Nancy Ames, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Harding SV, Eck P, Thandapilly SJ, Gamel TH, Abdel-Aal el-SM, Crow GH, Tosh SM, Jones PJ, Ames NP. High-Molecular-Weight beta-Glucan Decreases Serum Cholesterol Differentially Based on the CYP7A1 rs3808607 Polymorphism in Mildly Hypercholesterolemic Adults. J Nutr. 2016 Apr;146(4):720-7. doi: 10.3945/jn.115.223206. Epub 2016 Mar 2.