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

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.

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