Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Full fat dairy
* Other: Low fat dairy
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full fat dairy group<br>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 | Other: Full fat dairy<br>* 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<br>|
| Experimental: Low fat dairy group<br>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 | Other: Low fat dairy<br>* 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<br>|
| Other: Control group<br>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 | Other: Control<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1C (A1C) |  | Baseline, 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |