Insulin SensitivityNCT05421390
Effect of Dairy Products on Insulin Resistance
A study testing Reduced fat dairy and Regular fat dairy in people with Insulin Sensitivity and Glucose Intolerance, 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 consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (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
- Insulin Sensitivity, Glucose Intolerance, PreDiabetes
- What is being tested?
- Reduced fat dairy and Regular fat dairy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2022to 18 Oct 2024
- 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,
- Body mass index of 25-40 kg/m2,
- Waist circumference ≥94 cm for men, ≥80 cm for women,
- One or more indicators of prediabetes:
Show all 9Show fewer
- 5.7-6.4% HbA1c
- fasting 5.6-6.9 mmol/L glucose, or
- 7.8-11.0 mmol/L glucose at 2-h 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,
Show all 17Show fewer
- 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 (vitamin D, calcium, multivitamins, herbal remedies),
- Serum creatinine > 120 µmol/L,
- Hemoglobin < 120 g/L,
- Liver function tests ≥ 2× upper limit,
- Positive viral serology,
- Inaccessible veins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dairy Products on Insulin Resistance in Overweight and Obese Individuals With Prediabetes
The objective of the study is to determine the effect of dairy consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (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 reduced-fat dairy. 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 in a manner that prevents 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. Serum lipidomic and global gene expression responses to the intervention in subcutaneous adipose tissue will be measured as exploratory variables. Adherence to intervention will be assessed at each visit by food diaries, a record of consumed dairy products, and serum proportion of 15:0, 17:0, and t16:1n7 fatty acids as objective biomarkers of dairy fat intake.
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 reduced-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 be used to 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, eight, height, waist circumference, blood pressure, and pulse will be measured. Standard blood and urine tests, an OGTT, chest X-ray, electrocardiogram, and a physical exam 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 incorporating 1 serving of reduced-fat dairy products each day into their habitual diet. 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. A biopsy of subcutaneous adipose tissue from the thigh will be taken at fasting.
During the 12-week intervention, participants in the limited dairy group will be instructed to limit their intake of dairy products to ≤1 serving/d of dairy. Participants in the 2-3 dairy servings of reduced or regular fat dairy groups will be provided with the study products. 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 to measure fatty acid biomarkers of dairy intake. On the second monthly visit, they will also 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 undergo an oral glucose tolerance test, as well as blood and urine tests, as described for the first visit.
- Conditions
- Insulin Sensitivity, Glucose Intolerance, PreDiabetes
- Being tested
- Reduced fat dairy, Regular fat dairy
- Medical subject headings
- Insulin Resistance, Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced fat dairyOther
Serving sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. Skim milk, fat-free yogurt, and ≤22 % fat cheese
Regular fat dairyOther
Serving sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. 3.25% fat milk, ≥2% fat yogurt, and ≥28% fat cheese
| Study group | Role | What they receive |
|---|---|---|
| ≤1 dairy serving/day | No intervention | Limited dairy intake |
| 2-3 servings/day reduced-fat | Experimental | 2-3 servings/day of skim milk, fat-free yogurt, and low-fat cheese Receives: Other: Reduced fat dairy |
| 2-3 servings/day regular-fat | Experimental | 2-3 servings/day of regular-fat milk, yogurt, and cheese Receives: Other: Regular fat dairy |
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: Difference between baseline and 12-weeks intervention visit
Secondary outcomes (17)
Change in glucose tolerance
Change in glucose tolerance as measured by plasma glucose concentration at 2-h oral glucose tolerance test
Measured: Difference between screening and 13-week follow-up visit
Change in Matsuda index
Change in Matsuda index as measured by plasma glucose and insulin concentration during an oral glucose tolerance test
Measured: Difference between screening and 13-week follow-up visit
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: Difference between screening and 13-week follow-up visit
Change in oral disposition index
Change in oral disposition index as measured by the product of the Matsuda index and Insulinogenic index
Measured: Difference between screening and 13-week follow-up visit
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: Difference between screening and 13-week follow-up visit
Change in glycated hemoglobin
Change in fasting serum glycated hemoglobin percent
Measured: Difference between screening and 13-week follow-up visit
Change in total lean body mass
Change in total lean body mass as measured by dual-energy X-ray absorptiometry
Measured: Difference between baseline and 12-weeks intervention visit
Change in total fat mass
Change in total fat mass as measured by dual-energy X-ray absorptiometry
Measured: Difference between baseline and 12-weeks intervention visit
Change in visceral fat mass
Change in visceral fat mass as estimated by dual-energy X-ray absorptiometry
Measured: Difference between baseline and 12-weeks intervention visit
Change in systolic blood pressure
Change in systolic blood pressure as measured by automated blood pressure monitor.
Measured: Difference between baseline and 12-weeks intervention visit
Change in diastolic blood pressure
Change in diastolic blood pressure as measured by automated blood pressure monitor.
Measured: Difference between baseline and 12-weeks intervention visit
Change in total cholesterol
Change in total cholesterol as measured by fasting serum concentration
Measured: Difference between baseline and 12-weeks intervention visit
Change in total triglycerides
Change in total triglycerides as measured by fasting serum triglycerides
Measured: Difference between baseline and 12-weeks intervention visit
Change in total LDL-cholesterol
Change in total LDL-cholesterol as measured as calculated from fasting serum total cholesterol, HDL-cholesterol, and triglycerides
Measured: Difference between baseline and 12-weeks intervention visit
Change in total HDL-cholesterol
Change in total HDL-cholesterol as measured by fasting serum total HDL-cholesterol
Measured: Difference between baseline and 12-weeks intervention visit
Change in total non-HDL-cholesterol
Change in total non-HDL-cholesterol as calculated from fasting serum total cholesterol and HDL-cholesterol
Measured: Difference between baseline and 12-weeks intervention visit
Change in C-reactive protein
Change in fasting serum C-reactive protein concentration
Measured: Difference between baseline and 12-weeks intervention visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start10 Jun 2022
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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 A Burgos, PhD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421390
- Sponsor's protocol ID
- 2022-7468
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dairy Products on Insulin Resistance in Overweight and Obese Individuals With Prediabetes
- ClinicalTrials.gov ID
- NCT05421390
- Acronym / sponsor ID
- 2022-7468
- Conditions
- Insulin Sensitivity, Glucose Intolerance, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 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
- 10 Jun 2022 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 16 Jun 2022 (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 consumption on insulin sensitivity in overweight and obese adults with prediabetes. Men and women (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 reduced-fat dairy. 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 in a manner that prevents 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. Serum lipidomic and global gene expression responses to the intervention in subcutaneous adipose tissue will be measured as exploratory variables. Adherence to intervention will be assessed at each visit by food diaries, a record of consumed dairy products, and serum proportion of 15:0, 17:0, and t16:1n7 fatty acids as objective biomarkers of dairy fat intake.
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 reduced-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 be used to 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, eight, height, waist circumference, blood pressure, and pulse will be measured. Standard blood and urine tests, an OGTT, chest X-ray, electrocardiogram, and a physical exam 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 incorporating 1 serving of reduced-fat dairy products each day into their habitual diet. 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. A biopsy of subcutaneous adipose tissue from the thigh will be taken at fasting.
During the 12-week intervention, participants in the limited dairy group will be instructed to limit their intake of dairy products to ≤1 serving/d of dairy. Participants in the 2-3 dairy servings of reduced or regular fat dairy groups will be provided with the study products. 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 to measure fatty acid biomarkers of dairy intake. On the second monthly visit, they will also 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 undergo an oral glucose tolerance test, as well as blood and urine tests, as described for the first visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ≤1 dairy serving/day | No intervention | –Limited dairy intake |
| 2-3 servings/day reduced-fat | Experimental | Other: Reduced fat dairy2-3 servings/day of skim milk, fat-free yogurt, and low-fat cheese |
| 2-3 servings/day regular-fat | Experimental | Other: Regular fat dairy2-3 servings/day of regular-fat milk, yogurt, and cheese |
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,
- Body mass index of 25-40 kg/m2,
- Waist circumference ≥94 cm for men, ≥80 cm for women,
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 |
|---|---|---|
| Reduced fat dairyServing sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. Skim milk, fat-free yogurt, and ≤22 % fat cheese | Other | 2-3 servings/day reduced-fat |
| Regular fat dairyServing sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. 3.25% fat milk, ≥2% fat yogurt, and ≥28% fat cheese | Other | 2-3 servings/day regular-fat |
Primary outcome
Change in whole-body insulin sensitivity
Time frame: Difference between baseline and 12-weeks intervention visit
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)
17 secondary outcomes
Change in glucose tolerance
Time frame: Difference between screening and 13-week follow-up visit
Change in Matsuda index
Time frame: Difference between screening and 13-week follow-up visit
Change in Insulinogenic index
Time frame: Difference between screening and 13-week follow-up visit
Change in oral disposition index
Time frame: Difference between screening and 13-week follow-up visit
Change in Homeostatic Model Assessment for Insulin Resistance
Time frame: Difference between screening and 13-week follow-up visit
Change in glycated hemoglobin
Time frame: Difference between screening and 13-week follow-up visit
Change in total lean body mass
Time frame: Difference between baseline and 12-weeks intervention visit
Change in total fat mass
Time frame: Difference between baseline and 12-weeks intervention visit
Change in visceral fat mass
Time frame: Difference between baseline and 12-weeks intervention visit
Change in systolic blood pressure
Time frame: Difference between baseline and 12-weeks intervention visit
Change in diastolic blood pressure
Time frame: Difference between baseline and 12-weeks intervention visit
Change in total cholesterol
Time frame: Difference between baseline and 12-weeks intervention visit
Change in total triglycerides
Time frame: Difference between baseline and 12-weeks intervention visit
Change in total LDL-cholesterol
Time frame: Difference between baseline and 12-weeks intervention visit
Change in total HDL-cholesterol
Time frame: Difference between baseline and 12-weeks intervention visit
Change in total non-HDL-cholesterol
Time frame: Difference between baseline and 12-weeks intervention visit
Change in C-reactive protein
Time frame: Difference between baseline and 12-weeks intervention visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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 A Burgos, PhD principal investigator
RI-MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced fat dairy and Regular fat dairy in people with Insulin Sensitivity and Glucose Intolerance, 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: finished, as of the sponsor's last update on 11 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Difference between baseline and 12-weeks intervention visit). 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 11 Aug 2026.