An interventional study of 250 mL serving size, 3.25% fat content and 175 g serving size, ≥2% fat content in PreDiabetes and Overweight and Obesity, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Withdrawn at 1 site in Canada. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Other
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 serving/d of regular-fat dairy products (milk, yogurt, or cheese). Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d 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.
The randomized controlled trial will be preceded by a 2-week run-in period in which participants will consume 1 serving/day of regular-fat dairy. Following the run-in period, adherent participants will be randomly assigned to one of the three treatment groups (n=20 per group) in a 1:1:1 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 servings/day 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.
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One or more indicators of prediabetes:
Exclusion Criteria:
Milk
Other: 250 mL serving size, 3.25% fat content
Yogurt
Other: 175 g serving size, ≥2% fat content
Cheese
Other: 50 g serving size, ≥28% fat content
Milk
Yogurt
Cheese
Change in whole-body insulin sensitivity
Change in whole-body insulin sensitivity as measured by glucose infusion rate during the last 30 min of a hyperinsulinemic-euglycemic clamp divided by serum insulin concentration at the same period (M/I)
Time frame: 12 weeks
Change in glucose tolerance
Change in glucose tolerance as measured by plasma glucose concentration at 2-h oral glucose tolerance test
Time frame: 13 weeks
Change in Matsuda index
Change in Matsuda index as measured by plasma glucose and insulin concentration during an oral glucose tolerance test
Time frame: 13 weeks
Change in Insulinogenic index
Change in Insulinogenic index as measured by the ratio of serum c-peptide concentration and plasma glucose at 30 min minus 0 min during an oral glucose tolerance test
Time frame: 13 weeks
Change in oral disposition index
Change in oral disposition index as measured by the product of the Matsuda index and Insulinogenic index
Time frame: 13 weeks
Change in Homeostatic Model Assessment for Insulin Resistance
Change in Homeostatic Model Assessment for Insulin Resistance as calculated from fasting glucose and insulin concentration
Time frame: 13 weeks
Change in glycated hemoglobin
Change in fasting serum glycated hemoglobin percent
Time frame: 13 weeks
Change in total lean body mass
Change in total lean body mass as measured by dual-energy X-ray absorptiometry
Time frame: 12 weeks
Change in total fat mass
Change in total fat mass as measured by dual-energy X-ray absorptiometry
Time frame: 12 weeks
Change in visceral fat mass
Change in visceral fat mass as estimated by dual-energy X-ray absorptiometry
Time frame: 12 weeks
Change in systolic blood pressure
Change in systolic blood pressure as measured by automated blood pressure monitor.
Time frame: 12 weeks
Change in diastolic blood pressure
Change in diastolic blood pressure as measured by automated blood pressure monitor.
Time frame: 12 weeks
Change in lipid profile
Change in total, LDL-cholesterol as measured as calculated from fasting serum total cholesterol, HDL-cholesterol, and triglycerides
Time frame: 12 weeks
Change in resting energy expenditure
Change in resting energy expenditure as measured by indirect calorimetry
Time frame: 12 weeks
Change in total energy expenditure
Change in total energy expenditure as measured by accelerometry
Time frame: 12 weeks
Change in metabolic equivalent of task
Change in metabolic equivalent of task as measured by accelerometry
Time frame: 12 weeks
Change in total energy intake
Change in total energy intake as calculated from 3-d food records
Time frame: 12 weeks
Plan to share: No
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This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre