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Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions: Insulin Sensitivity, Glucose Intolerance, PreDiabetes
Interventions: Reduced fat dairy, Regular fat dairy
Countries: Canada
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.
Sex: ALL
Age: 30 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * 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: 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: * 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.
- Montreal, Quebec, Canada