- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06322940
Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sergio Burgos, PhD
- Phone Number: (514) 398-7802
- Email: sergio.burgos@mcgill.ca
Study Contact Backup
- Name: Catherine Vanstone, MSc, RN
- Phone Number: (514) 966-1335
- Email: catherine.vanstone@muhc.mcgill.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H4A 3J1
- RI-MUHC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 30 and 65 years,
- Able to provide informed consent,
- Stable weight and dietary habits over a period of 3 months (assessed though questions included in the screening questionnaire regarding changes in weight and dietary habits over the past three months from the date of the screening visit),
- Body mass index of 25-40 kg/m2,
- Waist circumference will follow the International Diabetes Federation ethnic-specific definition (≥94 cm for Europid males, ≥90 cm for Asian males, ≥80 cm for females),
One or more indicators of prediabetes:
- 5.7-6.4% HbA1c
- fasting 5.6-6.9 mmol/L glucose, or
- 7.8-11.0 mmol/L glucose at 2-hour oral glucose tolerance test (OGTT)
Exclusion Criteria:
- Current smokers,
- Pregnant or planning to become pregnant in the next 6 months,
- Breastfeeding,
- Participation in a weight loss program in the past 3 months,
- Dairy allergy or lactose intolerance,
- Any diagnosed eating disorders,
- Substance abuse (drugs or alcohol >3 drinks/day),
- Diagnosed medical conditions such as cardiovascular disease, anemia, kidney disease, liver disease and any cancer, other than skin, within 5 years.
- Diabetes diagnosis,
- Abnormal electrocardiogram or chest X-Ray,
- Treatment with diuretics, certain β-blockers, bronchodilators, daily nonsteroidal anti-inflammatory drugs, anticoagulants or antiplatelet agents (except prophylactic aspirin 81 mg/d), antianginals, antiarrhythmics, oral steroids, or other medications known to affect glucose metabolism,
- Refusal to temporarily stop taking supplements (minerals, micronutrients, herbal remedies),
- Serum creatinine > 120 µmol/L,
- Hemoglobin < 120 g/L,
- Liver function tests ≥ 3× upper limit,
- Positive viral serology,
- Inaccessible veins.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2-3 servings of regular-fat milk
Milk
|
Milk
|
Experimental: 2-3 servings of regular-fat yogurt
Yogurt
|
Yogurt
|
Experimental: 2-3 servings of regular-fat cheese
Cheese
|
Cheese
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in whole-body insulin sensitivity
Time Frame: 12 weeks
|
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)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glucose tolerance
Time Frame: 13 weeks
|
Change in glucose tolerance as measured by plasma glucose concentration at 2-h oral glucose tolerance test
|
13 weeks
|
Change in Matsuda index
Time Frame: 13 weeks
|
Change in Matsuda index as measured by plasma glucose and insulin concentration during an oral glucose tolerance test
|
13 weeks
|
Change in Insulinogenic index
Time Frame: 13 weeks
|
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
|
13 weeks
|
Change in oral disposition index
Time Frame: 13 weeks
|
Change in oral disposition index as measured by the product of the Matsuda index and Insulinogenic index
|
13 weeks
|
Change in Homeostatic Model Assessment for Insulin Resistance
Time Frame: 13 weeks
|
Change in Homeostatic Model Assessment for Insulin Resistance as calculated from fasting glucose and insulin concentration
|
13 weeks
|
Change in glycated hemoglobin
Time Frame: 13 weeks
|
Change in fasting serum glycated hemoglobin percent
|
13 weeks
|
Change in total lean body mass
Time Frame: 12 weeks
|
Change in total lean body mass as measured by dual-energy X-ray absorptiometry
|
12 weeks
|
Change in total fat mass
Time Frame: 12 weeks
|
Change in total fat mass as measured by dual-energy X-ray absorptiometry
|
12 weeks
|
Change in visceral fat mass
Time Frame: 12 weeks
|
Change in visceral fat mass as estimated by dual-energy X-ray absorptiometry
|
12 weeks
|
Change in systolic blood pressure
Time Frame: 12 weeks
|
Change in systolic blood pressure as measured by automated blood pressure monitor.
|
12 weeks
|
Change in diastolic blood pressure
Time Frame: 12 weeks
|
Change in diastolic blood pressure as measured by automated blood pressure monitor.
|
12 weeks
|
Change in lipid profile
Time Frame: 12 weeks
|
Change in total, LDL-cholesterol as measured as calculated from fasting serum total cholesterol, HDL-cholesterol, and triglycerides
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in resting energy expenditure
Time Frame: 12 weeks
|
Change in resting energy expenditure as measured by indirect calorimetry
|
12 weeks
|
Change in total energy expenditure
Time Frame: 12 weeks
|
Change in total energy expenditure as measured by accelerometry
|
12 weeks
|
Change in metabolic equivalent of task
Time Frame: 12 weeks
|
Change in metabolic equivalent of task as measured by accelerometry
|
12 weeks
|
Change in total energy intake
Time Frame: 12 weeks
|
Change in total energy intake as calculated from 3-d food records
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sergio Burgos, PhD, McGill University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-10463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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