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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
112
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
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
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
Joslin Diabetes Center
Boston, Massachusetts, United States
Change in Hemoglobin A1C (A1C)
Time frame: Baseline, 12 weeks and 24 weeks
Change in body weight
Time frame: Baseline, 12 weeks and 24 weeks
Change in total cholesterol
Time frame: Baseline, 12 weeks and 24 weeks
Change in high-density lipoprotein (HDL)
Time frame: Baseline, 12 weeks and 24 weeks
Change in low-density lipoprotein (LDL)
Time frame: Baseline, 12 weeks and 24 weeks
Change in triglycerides
Time frame: Baseline, 12 weeks and 24 weeks
Change in fasting plasma glucose
Time frame: Baseline, 12 weeks and 24 weeks
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
Time frame: Baseline, 12 weeks and 24 weeks
Change in body fat percentage
Time frame: Baseline, 12 weeks and 24 weeks
Change in fat free mass
Time frame: Baseline, 12 weeks and 24 weeks
Height in meters
Used in calculation of Body Mass Index
Time frame: Baseline
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Change in total body water
Time frame: Baseline, 12 weeks and 24 weeks
Change in waist circumference
Time frame: Baseline, 12 weeks and 24 weeks
Change in trunk fat percentage
Time frame: Baseline, 12 weeks and 24 weeks
Change in visceral fat level
Time frame: Baseline, 12 weeks and 24 weeks
Change in blood pressure
Time frame: Baseline, 12 weeks and 24 weeks
Change in c-reactive protein level
Time frame: Baseline, 12 weeks and 24 weeks