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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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Joslin Diabetes Center
Boston, Massachusetts, United States
Start Date
May 1, 2016
Primary Completion Date
July 1, 2018
Completion Date
August 1, 2018
Last Updated
March 1, 2019
112
ACTUAL participants
Full fat dairy
OTHER
Low fat dairy
OTHER
Control
OTHER
Lead Sponsor
Joslin Diabetes Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587