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
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-06-10
2024-10-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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≤1 dairy serving/day
Limited dairy intake
No interventions assigned to this group
2-3 servings/day reduced-fat
2-3 servings/day of skim milk, fat-free yogurt, and low-fat cheese
Reduced fat dairy
Serving sizes will be: 250 mL milk, 175 g yogurt, and 50 g cheese. Skim milk, fat-free yogurt, and ≤22 % fat cheese
2-3 servings/day regular-fat
2-3 servings/day of regular-fat milk, yogurt, and cheese
Regular fat dairy
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
Interventions
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Reduced fat dairy
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 dairy
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
Eligibility Criteria
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Inclusion Criteria
* 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:
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-h 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 (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.
30 Years
65 Years
ALL
Yes
Sponsors
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Dairy Farmers of Canada
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Sergio Burgos
Associate Professor
Principal Investigators
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Sergio A Burgos, PhD
Role: PRINCIPAL_INVESTIGATOR
RI-MUHC
Locations
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RI-MUHC
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2022-7468
Identifier Type: -
Identifier Source: org_study_id