Effect of Canned Beans of Multiple Varieties in Daily Amounts of 1 Cup and 1/2 Cup on Serum LDL Cholesterol and Other Cardiovascular Disease Risk Biomarkers in Adults With Elevated LDL Cholesterol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Fasting serum LDL cholesterol
研究概览
简要总结
The Bean Study will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated LDL cholesterol.
详细描述
The Bean Study (TBS) is a a multi-centre, randomized, crossover design study which will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated LDL cholesterol. Participants will consume daily amounts of 1 cup canned beans, ½ cup of canned beans and 1 cup of white rice for 4 weeks each, separated by minimum 4-week washout periods. At the start and end of each 4-week treatment period, fasting blood samples will be collected and analyzed for lipids, glucose insulin and short chain fatty acids (SCFAs). Fecal samples will also be collected and analyzed for SCFA, bile acids and gut microbiota. Body weight and BMI will be also be measured at the start and end as well as mid-way of each treatment period. Finally 3-day food records will be completed mid-way during each treatment period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults (≥18 years)
- •BMI 18.5-35 kg/m2
- •LDL cholesterol 3.0-5.0 mmol/L
排除标准
- •Triglycerides ≥3.0 mmol/L
- •Diabetes (fasting blood glucose ≥7.0 mmol/L)
- •Blood pressure >140/90 mmHg
- •Major medical conditions
- •Medical or surgical events requiring hospitalization within the last 3 months
- •Medication use that would interfere with the study outcomes (e.g. cholesterol-lowering medications, diabetes-related medications, steroids). All other medications are okay if at a stable (3-month) dose
- •Antibiotic use within the last 3 months
- •Tobacco product use (>5 times per week)
- •Cannabis use during the study
- •Probiotic supplement use (could do a 1-month washout before study)
- •Dietary fibre supplement use (could do a 1-month washout before study)
- •NHPs used for cholesterol lowering or glycemic control. All other NHPs are okay if at a stable (3-month) dose.
- •Pulse consumption >4 servings per week
- •Food allergy or non-food life-threatening allergy
- •Pregnant or breastfeeding
- •Alcohol consumption (>14 drinks/week or >4 drinks/sitting)
- •Recent or intended significant weight loss or gain (>4 kg in previous 3 months)
- •National-level or professional athlete
- •Overnight shift worker
结局指标
主要结局
Fasting serum LDL cholesterol
时间窗: 4 weeks (28 days)
Fasting serum LDL cholesterol will be compared among treatments at study day 29 using ANCOVA and including study day 1 as a covariate
次要结局
- Fasting serum total cholesterol, HDL cholesterol and triglycerides(4 weeks (28 days))
- Fasting serum glucose and insulin and HOMA-IR(4 weeks (28 days))
- Fasting serum and fecal short chain fatty acids(4 weeks (28 days))
- Fecal bile acids(4 weeks (28 days))
- Gut Microbiota(4 weeks (28 days))
研究者
Alison Duncan
Professor
University of Guelph