Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Changs in Total Cholesterol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changs in Total Cholesterol
时间窗: Beginning and end of each phase
Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Changes in LDL Cholesterol
时间窗: Beginning and end of each phase
Serum LDL cholesterol will be estimated using the Friedewald equation.
次要结局
- Cholesterol Absorption/Synthesis(End of each phase)
- Potential Gene-nutrient Interactions: CYP7A1 and APOE(Once for each participant)
- Changes in Body Weight and Waist Circumference(WC)(Every day for body weight; beginning and end of each phase for WC)
研究者
Dr. Nancy Ames
Research Scientist & Adjunct Professor
University of Manitoba