Impact of Pinto Beans as Part of a Normal Diet on Glycemic Control in Adults With Type 2 Diabetes: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Change in Glucose
研究概览
简要总结
This study examines the impact of daily consumption of ½ c pinto beans, compared to a control (½ c green beans), on fasting glucose, postprandial glucose and HbA1c concentrations in adults with type 2 diabetes mellitus (T2DM).
详细描述
This study utilized a randomized, pretest-posttest, crossover (within-group) design, that includes two treatment periods [control period (½ c. green beans each day) and pinto beans (½ c each day)], each 12-weeks in duration with a 4- week wash-out period to determine the impact on fasting glucose, postprandial glucose and HbA1c concentrations. After a baseline wash-in period, 16 participants are randomly assigned to 2 treatment periods [control period and pinto beans], each 12-weeks in duration. On 28 randomized days during the wash-in period and interventions, participants keep diet records and measure a postprandial capillary glucose concentration using a glucometer 1 hour after the meal during which the pinto beans or control are consumed. Before and after each 12-week intervention, participants provide a fasted venous blood sample for glucose and HbA1c analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of T2DM by a physician;
- •currently attempting control of T2DM by diet or metformin;
- •fasting glucose ≥ 90 mg/dL (confirmed by fasting blood draw or potential participant provided lab analysis conducted within last 30 days) and/or hemoglobin A1C ≥ 6.5% (confirmed by blood draw or potential participant provided lab analysis conducted within last 30 days);
- •body mass index (BMI) of 22-40 kg/m2;
- •no unresolved health conditions and no diagnosis of gastrointestinal disease;
- •limited history of legume intake;
- •willingness to follow study protocol, scheduling, and ability to come to the testing location;
- •no recent weight gain or loss (>10% over 6 months);
- •no use of medications and/or dietary supplements other than metformin that affected glucose;
- •women could not be pregnant or breastfeeding;
- •habitual alcohol consumption had to be less than 2 drinks per day (specifically ≤ 720 ml of beer, 240 ml of wine, or 90 ml of hard liquor).
排除标准
- •Non compliance with above inclusion criteria.
结局指标
主要结局
Change in Glucose
时间窗: 12 weeks pre and post
Change in fasting blood glucose levels
次要结局
- Change in Hemoglobin A1c(12 weeks pre and post)
- Postprandial glucose(1 time per week from week 1 of each intervention to week 12 of each intervention)
研究者
Andrea Hutchins
Associate Professor
University of Colorado, Colorado Springs