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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full fat dairy group | Experimental | 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 | Experimental | 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 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full fat dairy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1C (A1C) | Baseline, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline, 12 weeks and 24 weeks | |
| Change in total cholesterol | Baseline, 12 weeks and 24 weeks | |
| Change in high-density lipoprotein (HDL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osama Hamdy, M.D., Ph.D. | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32520346 | Derived | Mitri J, Tomah S, Mottalib A, Salsberg V, Ashrafzadeh S, Pober DM, Eldib AH, Tasabehji MW, Hamdy O. Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study. Am J Clin Nutr. 2020 Aug 1;112(2):293-302. doi: 10.1093/ajcn/nqaa138. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Low fat dairy | Other | 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 |
|
| Control | Other | 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 |
|
| Baseline, 12 weeks and 24 weeks |
| Change in low-density lipoprotein (LDL) | 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 body fat percentage | Baseline, 12 weeks and 24 weeks |
| Change in fat free mass | Baseline, 12 weeks and 24 weeks |
| Height in meters | Used in calculation of Body Mass Index | 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 visceral fat level | 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 |
| D004700 | Endocrine System Diseases |