Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Other: Full fat dairyOther: Low fat dairyOther: Control
- Registration Number
- NCT02895867
- Lead Sponsor
- Joslin Diabetes Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full fat dairy group Full fat dairy 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 Low fat dairy group Low fat dairy 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 Control group Control 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
- Primary Outcome Measures
Name Time Method Change in Hemoglobin A1C (A1C) Baseline, 12 weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method Change in total cholesterol Baseline, 12 weeks and 24 weeks Height in meters Baseline Used in calculation of Body Mass Index
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 high-density lipoprotein (HDL) 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 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
Trial Locations
- Locations (1)
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States