Effect of Dairy Product Matrices on Insulin Resistance in People with Overweight and Obesity and Prediabetes
NCT ID: NCT06322940
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2024-09-30
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2-3 servings of regular-fat milk
Milk
250 mL serving size, 3.25% fat content
Milk
2-3 servings of regular-fat yogurt
Yogurt
175 g serving size, ≥2% fat content
Yogurt
2-3 servings of regular-fat cheese
Cheese
50 g serving size, ≥28% fat content
Cheese
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
250 mL serving size, 3.25% fat content
Milk
175 g serving size, ≥2% fat content
Yogurt
50 g serving size, ≥28% fat content
Cheese
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. 5.7-6.4% HbA1c
2. fasting 5.6-6.9 mmol/L glucose, or
3. 7.8-11.0 mmol/L glucose at 2-hour oral glucose tolerance test (OGTT)
Exclusion Criteria
* 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.
30 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dairy Farmers of Canada
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sergio Burgos
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sergio Burgos, PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
RI-MUHC
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-10463
Identifier Type: -
Identifier Source: org_study_id