Effect of Chia Seeds (Salvia Hispanica L.) on Glucose Control in Patients With Type 2 Diabetes
研究概览
详细说明
Cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. Grain of the plant Salvia hispanica alba (Salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. To address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain Salba in type 2 diabetes.
Comparison(s): Participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of Salba or matched control supplement for 12 weeks separated by a 4-week washout period.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5C2T2
- St. Michael's Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All men or postmenopausal women with Type 2 diabetes optimally or suboptimally controlled (HbA1C < 9.0%) on oral hypoglycemic agents or diet only were asked to participate.
Exclusion Criteria:
- Those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement therapy, with BMI>38 kg/m2, smoking or significant alcohol intake (>2 drinks/day), serum TG >4.0 mmol/L, and those with complications of diabetes were excluded. Subjects were also excluded if they regularly took fish oil and flax seed supplements or used steroids. Subjects were excluded during the course of the study if there were any changes to their regular antihypertensive, lipid, or oral hypoglycemic medications, if unable to consume >50% of supplements provided, had a significant weight change (defined as >2.5 kg), or if their level of physical activity did not remain constant over the course of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
血红蛋白 A1c
|
次要结果测量
结果测量 |
|---|
|
Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors)
|
|
safety (liver, kidney and haemostatic function)
|
|
compliance (plasma fatty-acids, returned supplements, diet records, body weight).
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.