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Completed

NCT Number: NCT02895867

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full fat dairy

Other

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

Other

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

Other

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

Primary outcomes

  1. Change in Hemoglobin A1C (A1C)

    Time frame: Baseline, 12 weeks and 24 weeks

Secondary outcomes

  1. Change in body weight

    Time frame: Baseline, 12 weeks and 24 weeks

  2. Change in total cholesterol

    Time frame: Baseline, 12 weeks and 24 weeks

  3. Change in high-density lipoprotein (HDL)

    Time frame: Baseline, 12 weeks and 24 weeks

  4. Change in low-density lipoprotein (LDL)

    Time frame: Baseline, 12 weeks and 24 weeks

  5. Change in triglycerides

    Time frame: Baseline, 12 weeks and 24 weeks

  6. Change in fasting plasma glucose

    Time frame: Baseline, 12 weeks and 24 weeks

  7. Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline

    Time frame: Baseline, 12 weeks and 24 weeks

  8. Change in body fat percentage

    Time frame: Baseline, 12 weeks and 24 weeks

  9. Change in fat free mass

    Time frame: Baseline, 12 weeks and 24 weeks

  10. Height in meters

    Time frame: Baseline

    Used in calculation of Body Mass Index

  11. Change in total body water

    Time frame: Baseline, 12 weeks and 24 weeks

  12. Change in waist circumference

    Time frame: Baseline, 12 weeks and 24 weeks

  13. Change in trunk fat percentage

    Time frame: Baseline, 12 weeks and 24 weeks

  14. Change in visceral fat level

    Time frame: Baseline, 12 weeks and 24 weeks

  15. Change in blood pressure

    Time frame: Baseline, 12 weeks and 24 weeks

  16. Change in c-reactive protein level

    Time frame: Baseline, 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2016
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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