Effect of Dairy Product Matrices on Insulin Resistance in People with Overweight and Obesity and Prediabetes
Reason given: Lack of funding
Key facts
- Where
- Montreal, CanadaSee the site
Where in Canada
- RI-MUHCMontreal, CanadaNo longer taking part
Trial details
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Trial code
- NCT06322940
- Record updated
- 27 December 2024
- Original description
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 full original descriptionShow less
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.
Inclusion: 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:; 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).
Exclusion: Substance abuse (drugs or alcohol >3 drinks/day),; Dairy allergy or lactose intolerance,; Any diagnosed eating disorders,; Diagnosed medical conditions such as cardiovascular disease, anemia, kidney disease, liver disease and any cancer, other than skin, within 5 years; Diabetes diagnosis,; 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,; Serum creatinine > 120 µmol/L,; Hemoglobin < 120 g/L,; 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,; Abnormal electrocardiogram or chest X-Ray,; Refusal to temporarily stop taking supplements (minerals, micronutrients, herbal remedies),; Liver function tests ≥ 3× upper limit,; Positive viral serology,; Inaccessible veins.