Status:
COMPLETED
Effect of Dairy Products on Insulin Resistance
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Dairy Farmers of Canada
Conditions:
Insulin Sensitivity
Glucose Intolerance
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief 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 gr...
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 wil...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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 (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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05421390
Start Date
June 10 2022
End Date
October 18 2024
Last Update
December 27 2024
Active Locations (1)
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1
RI-MUHC
Montreal, Quebec, Canada, H4A 3J1