Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes
NCT ID: NCT02895867
Last Updated: 2019-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2016-05-31
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
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 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
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 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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Joslin Diabetes Center
OTHER
Responsible Party
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Principal Investigators
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Osama Hamdy, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Locations
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Joslin Diabetes Center
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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2016-04
Identifier Type: -
Identifier Source: org_study_id
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