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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895867
• Other study ID #: 2016-04
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2019
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Full fat dairy
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
• Low fat dairy
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
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

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C (A1C)		Baseline, 12 weeks and 24 weeks
Secondary	Change in body weight		Baseline, 12 weeks and 24 weeks
Secondary	Change in total cholesterol		Baseline, 12 weeks and 24 weeks
Secondary	Change in high-density lipoprotein (HDL)		Baseline, 12 weeks and 24 weeks
Secondary	Change in low-density lipoprotein (LDL)		Baseline, 12 weeks and 24 weeks
Secondary	Change in triglycerides		Baseline, 12 weeks and 24 weeks
Secondary	Change in fasting plasma glucose		Baseline, 12 weeks and 24 weeks
Secondary	Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline		Baseline, 12 weeks and 24 weeks
Secondary	Change in body fat percentage		Baseline, 12 weeks and 24 weeks
Secondary	Change in fat free mass		Baseline, 12 weeks and 24 weeks
Secondary	Height in meters	Used in calculation of Body Mass Index	Baseline
Secondary	Change in total body water		Baseline, 12 weeks and 24 weeks
Secondary	Change in waist circumference		Baseline, 12 weeks and 24 weeks
Secondary	Change in trunk fat percentage		Baseline, 12 weeks and 24 weeks
Secondary	Change in visceral fat level		Baseline, 12 weeks and 24 weeks
Secondary	Change in blood pressure		Baseline, 12 weeks and 24 weeks
Secondary	Change in c-reactive protein level		Baseline, 12 weeks and 24 weeks