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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1C (A1C)
研究概览
简要总结
This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Full fat dairy (Other)
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
干预措施: Low fat dairy (Other)
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
干预措施: Control (Other)
结局指标
主要结局
Change in Hemoglobin A1C (A1C)
时间窗: Baseline, 12 weeks and 24 weeks
次要结局
- Change in total cholesterol(Baseline, 12 weeks and 24 weeks)
- Height in meters(Baseline)
- Change in total body water(Baseline, 12 weeks and 24 weeks)
- Change in waist circumference(Baseline, 12 weeks and 24 weeks)
- Change in trunk fat percentage(Baseline, 12 weeks and 24 weeks)
- Change in blood pressure(Baseline, 12 weeks and 24 weeks)
- Change in c-reactive protein level(Baseline, 12 weeks and 24 weeks)
- Change in body weight(Baseline, 12 weeks and 24 weeks)
- Change in triglycerides(Baseline, 12 weeks and 24 weeks)
- Change in fasting plasma glucose(Baseline, 12 weeks and 24 weeks)
- Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline(Baseline, 12 weeks and 24 weeks)
- Change in high-density lipoprotein (HDL)(Baseline, 12 weeks and 24 weeks)
- Change in low-density lipoprotein (LDL)(Baseline, 12 weeks and 24 weeks)
- Change in body fat percentage(Baseline, 12 weeks and 24 weeks)
- Change in fat free mass(Baseline, 12 weeks and 24 weeks)
- Change in visceral fat level(Baseline, 12 weeks and 24 weeks)