Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study
研究概览
详细说明
This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups:
Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02215
- Joslin Diabetes Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
Inclusion Criteria:
- Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
- A1C ≥7 %
- Consuming <3 servings of dairy products per day
- On stable dose of diabetes, blood pressure or cholesterol medications for 3 months
- Body weight is within 10% of current weight over the last 6 months before starting the study
Exclusion Criteria:
- Pregnancy or lactation
- Lactose intolerance
- Allergy to milk or any of its components
- Use of orlistat
- History of pancreatitis
- History of gastric bypass surgery or sleeve gastrectomy
- Active malignancy
- History of recent cardiovascular event
- Having a heart pacemaker
- Enrollment in other studies that may affect study outcomes
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Full fat dairy group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
|
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
|
|
实验性的：Low fat dairy group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
|
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
|
|
其他：Control group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
|
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in Hemoglobin A1C (A1C)
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in body weight
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in total cholesterol
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in high-density lipoprotein (HDL)
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in low-density lipoprotein (LDL)
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in triglycerides
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in fasting plasma glucose
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in body fat percentage
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in fat free mass
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Height in meters
大体时间：Baseline
|
Used in calculation of Body Mass Index
|
Baseline
|
|
Change in total body water
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in waist circumference
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in trunk fat percentage
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in visceral fat level
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in blood pressure
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
|
|
Change in c-reactive protein level
大体时间：Baseline, 12 weeks and 24 weeks
|
Baseline, 12 weeks and 24 weeks
|
合作者和调查者
调查人员
- 首席研究员：Osama Hamdy, M.D., Ph.D.、Joslin Diabetes Center
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
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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