Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT02895867
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline
Used in calculation of Body Mass Index
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Time frame: Baseline, 12 weeks and 24 weeks
Joslin Diabetes Center
Other
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
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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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