Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322940
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-29
Brief Title:
Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to determine the effect of dairy product matrices on insulin sensitivity in overweight and obese adults with prediabetes Females and males 30-65 y will be recruited from the greater Montreal area Upon screening those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 servingd of regular-fat dairy products milk yogurt or cheese Adherent participants will be randomized by sex into 1 of 3 groups 1 servingd of dairy limited dairy or 2-3 servingsd of reduced-fat or regular-fat dairy for 12 weeks Participants will be instructed on how to incorporate foods into their diet to prevent changes in their body weight The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome In addition glycemic variables body composition and cardiometabolic risk factors will be assessed as secondary outcomes Adherence to intervention will be assessed at each visit by food diaries and a record of consumed dairy products
Detailed Description:
The randomized controlled trial will be preceded by a 2-week run-in period in which participants will consume 1 servingday of regular-fat dairy Following the run-in period adherent participants will be randomly assigned to one of the three treatment groups n20 per group in a 111 allocation ratio Stratified permuted block randomization will ensure adequate balance among groups using a computer-generated list of random numbers Due to the nature of the test products participants cannot be blinded to the diet intervention However outcome assessors will be blinded to treatment allocation
During the screening visit and after obtaining informed consent weight height waist circumference blood pressure and pulse will be measured Standard blood and urine tests an oral glucose tolerance test chest X-ray and an electrocardiogram will be performed In addition volunteers will be interviewed regarding demographic information medical and family history dietary habits and physical activity using questionnaires
At the run-in visit participants will retrieve their dairy products and a dietitian will instruct them on how to incorporate 1 daily serving of regular-fat dairy products into their habitual diet A physical exam will be performed Participants will be asked to record their food intake for 3 consecutive days including one weekend day They will also receive an accelerometer and instructions for use on the same 3-days they record their food intake Participants will maintain a daily record of consumed dairy products during the run-in periods and throughout the study
At the baseline and 12-week intervention visits participants will undergo a hyperinsulinemic-euglycemic clamp to assess systemic insulin sensitivity In addition body composition will be measured by dual-energy X-ray absorptiometry and resting energy expenditure by indirect calorimetry
During the 12-week intervention participants will be provided with the study products and instructed to consume 2-3 servingsday of regular fat milk yogurt or cheese Serving sizes will be 250 mL milk 175 g yogurt and 50 g cheese The dietitian will instruct participants individually on how to incorporate the dairy products into their habitual diets by reducing the intake of other foods of equivalent caloric content and complementary nutrient density to maintain stable body weight No additional dietary changes will be recommended
At the monthly follow-up visits weight blood pressure and pulse will be measured In addition participants will complete questionnaires about their health and physical activity At each visit they will be asked to track their food intake for 3 consecutive days including one weekend day using a mobile application on their smartphone or if not possible in written food diaries Additionally a blood sample will be collected On the second monthly visit they will receive an accelerometer and instructions for use on the same 3 days they record their food intake for the 12-week visit
At the final follow-up visit participants weight blood pressure and pulse will be measured and they will complete questionnaires regarding their health and activity They will also undergo an oral glucose tolerance test and blood tests as described for the screening visit
During the screening visit and after obtaining informed consent weight height waist circumference blood pressure and pulse will be measured Standard blood and urine tests an oral glucose tolerance test chest X-ray and an electrocardiogram will be performed In addition volunteers will be interviewed regarding demographic information medical and family history dietary habits and physical activity using questionnaires
At the run-in visit participants will retrieve their dairy products and a dietitian will instruct them on how to incorporate 1 daily serving of regular-fat dairy products into their habitual diet A physical exam will be performed Participants will be asked to record their food intake for 3 consecutive days including one weekend day They will also receive an accelerometer and instructions for use on the same 3-days they record their food intake Participants will maintain a daily record of consumed dairy products during the run-in periods and throughout the study
At the baseline and 12-week intervention visits participants will undergo a hyperinsulinemic-euglycemic clamp to assess systemic insulin sensitivity In addition body composition will be measured by dual-energy X-ray absorptiometry and resting energy expenditure by indirect calorimetry
During the 12-week intervention participants will be provided with the study products and instructed to consume 2-3 servingsday of regular fat milk yogurt or cheese Serving sizes will be 250 mL milk 175 g yogurt and 50 g cheese The dietitian will instruct participants individually on how to incorporate the dairy products into their habitual diets by reducing the intake of other foods of equivalent caloric content and complementary nutrient density to maintain stable body weight No additional dietary changes will be recommended
At the monthly follow-up visits weight blood pressure and pulse will be measured In addition participants will complete questionnaires about their health and physical activity At each visit they will be asked to track their food intake for 3 consecutive days including one weekend day using a mobile application on their smartphone or if not possible in written food diaries Additionally a blood sample will be collected On the second monthly visit they will receive an accelerometer and instructions for use on the same 3 days they record their food intake for the 12-week visit
At the final follow-up visit participants weight blood pressure and pulse will be measured and they will complete questionnaires regarding their health and activity They will also undergo an oral glucose tolerance test and blood tests as described for the screening visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None