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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full fat dairy
Low fat dairy
Control
Sponsored by
Joslin Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Joslin Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Full fat dairy group

Low fat dairy group

Control group

Arm 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

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

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

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1C (A1C)

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2016
Last Updated
February 28, 2019
Sponsor
Joslin Diabetes Center
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1. Study Identification

Unique Protocol Identification Number
NCT02895867
Brief Title
Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full fat dairy group
Arm Type
Experimental
Arm 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
Arm Title
Low fat dairy group
Arm Type
Experimental
Arm 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
Arm Title
Control group
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Full fat dairy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Low fat dairy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention 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
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1C (A1C)
Time Frame
Baseline, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in total cholesterol
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in high-density lipoprotein (HDL)
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in low-density lipoprotein (LDL)
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in triglycerides
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in fasting plasma glucose
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in body fat percentage
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in fat free mass
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Height in meters
Description
Used in calculation of Body Mass Index
Time Frame
Baseline
Title
Change in total body water
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in waist circumference
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in trunk fat percentage
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in visceral fat level
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in blood pressure
Time Frame
Baseline, 12 weeks and 24 weeks
Title
Change in c-reactive protein level
Time Frame
Baseline, 12 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Hamdy, M.D., Ph.D.
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32520346
Citation
Mitri J, Tomah S, Mottalib A, Salsberg V, Ashrafzadeh S, Pober DM, Eldib AH, Tasabehji MW, Hamdy O. Effect of dairy consumption and its fat content on glycemic control and cardiovascular disease risk factors in patients with type 2 diabetes: a randomized controlled study. Am J Clin Nutr. 2020 Aug 1;112(2):293-302. doi: 10.1093/ajcn/nqaa138.
Results Reference
derived

Learn more about this trial

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

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