PreDiabetesNCT06322940
Effect of Dairy Product Matrices on Insulin Resistance in People with Overweight and Obesity and Prediabetes
A study testing 250 mL serving size, 3.25% fat content, 175 g serving size, ≥2% fat content and 50 g serving size, ≥28% fat content in people with PreDiabetes and Overweight and Obesity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Overweight and Obesity
- What is being tested?
- 250 mL serving size, 3.25% fat content, 175 g serving size, ≥2% fat content and 50 g serving size, ≥28% fat content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- PreDiabetes, Overweight and Obesity
- Being tested
- 250 mL serving size, 3.25% fat content, 175 g serving size, ≥2% fat content, 50 g serving size, ≥28% fat content
- Keywords
- Dairy products, Insulin sensitivity, Glucose metabolism, Insulin resistance
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 mL serving size, 3.25% fat contentOther
Milk
175 g serving size, ≥2% fat contentOther
Yogurt
50 g serving size, ≥28% fat contentOther
Cheese
| Study group | Role | What they receive |
|---|---|---|
| 2-3 servings of regular-fat milk | Experimental | Milk Receives: Other: 250 mL serving size, 3.25% fat content |
| 2-3 servings of regular-fat yogurt | Experimental | Yogurt Receives: Other: 175 g serving size, ≥2% fat content |
| 2-3 servings of regular-fat cheese | Experimental | Cheese Receives: Other: 50 g serving size, ≥28% fat content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (12)
Change in glucose tolerance
Change in glucose tolerance as measured by plasma glucose concentration at 2-h oral glucose tolerance test
Measured: 13 weeks
Change in Matsuda index
Change in Matsuda index as measured by plasma glucose and insulin concentration during an oral glucose tolerance test
Measured: 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
Measured: 13 weeks
Change in oral disposition index
Change in oral disposition index as measured by the product of the Matsuda index and Insulinogenic index
Measured: 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
Measured: 13 weeks
Change in glycated hemoglobin
Change in fasting serum glycated hemoglobin percent
Measured: 13 weeks
Change in total lean body mass
Change in total lean body mass as measured by dual-energy X-ray absorptiometry
Measured: 12 weeks
Change in total fat mass
Change in total fat mass as measured by dual-energy X-ray absorptiometry
Measured: 12 weeks
Change in visceral fat mass
Change in visceral fat mass as estimated by dual-energy X-ray absorptiometry
Measured: 12 weeks
Change in systolic blood pressure
Change in systolic blood pressure as measured by automated blood pressure monitor.
Measured: 12 weeks
Change in diastolic blood pressure
Change in diastolic blood pressure as measured by automated blood pressure monitor.
Measured: 12 weeks
Change in lipid profile
Change in total, LDL-cholesterol as measured as calculated from fasting serum total cholesterol, HDL-cholesterol, and triglycerides
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study startSep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three treatment groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Principal investigator, Sergio Burgos, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Sergio Burgos, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322940
- Sponsor's protocol ID
- 2024-10463
- Status last verified
- Dec 2024
- First submitted
- 29 Feb 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dairy Product Matrices on Insulin Resistance in People with Overweight and Obesity and Prediabetes
- ClinicalTrials.gov ID
- NCT06322940
- Acronym / sponsor ID
- 2024-10463
- Conditions
- PreDiabetes, Overweight and Obesity
- Keywords
- Dairy products, Insulin sensitivity, Glucose metabolism, Insulin resistance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three treatment groups
| Arm | Type | Receives |
|---|---|---|
| 2-3 servings of regular-fat milk | Experimental | Other: 250 mL serving size, 3.25% fat contentMilk |
| 2-3 servings of regular-fat yogurt | Experimental | Other: 175 g serving size, ≥2% fat contentYogurt |
| 2-3 servings of regular-fat cheese | Experimental | Other: 50 g serving size, ≥28% fat contentCheese |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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),
Key exclusion criteria (17 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 250 mL serving size, 3.25% fat contentMilk | Other | 2-3 servings of regular-fat milk |
| 175 g serving size, ≥2% fat contentYogurt | Other | 2-3 servings of regular-fat yogurt |
| 50 g serving size, ≥28% fat contentCheese | Other | 2-3 servings of regular-fat cheese |
Primary outcome
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 secondary outcomes
Change in glucose tolerance
Time frame: 13 weeks
Change in Matsuda index
Time frame: 13 weeks
Change in Insulinogenic index
Time frame: 13 weeks
Change in oral disposition index
Time frame: 13 weeks
Change in Homeostatic Model Assessment for Insulin Resistance
Time frame: 13 weeks
Change in glycated hemoglobin
Time frame: 13 weeks
Change in total lean body mass
Time frame: 12 weeks
Change in total fat mass
Time frame: 12 weeks
Change in visceral fat mass
Time frame: 12 weeks
Change in systolic blood pressure
Time frame: 12 weeks
Change in diastolic blood pressure
Time frame: 12 weeks
Change in lipid profile
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Burgos, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 250 mL serving size, 3.25% fat content, 175 g serving size, ≥2% fat content and 50 g serving size, ≥28% fat content in people with PreDiabetes and Overweight and Obesity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in whole-body insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.