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

Joslin Diabetes Center

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Low fat dairy; Other: Full fat dairy; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02895867

2016-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

Full fat dairy group

Experimental group

Description:

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

Treatment:

Other: Full fat dairy

Low fat dairy group

Experimental group

Description:

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

Treatment:

Other: Low fat dairy

Control group

Other group

Description:

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

Treatment:

Other: Control