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

May 27, 2026 updated by: Joslin Diabetes Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full fat dairy group
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
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
Experimental: Low fat dairy group
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
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
Other: Control group
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Investigators

  • Principal Investigator: Osama Hamdy, M.D., Ph.D., Joslin Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimated)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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