Effect of Dairy Product Matrices on Insulin Resistance in People with Overweight and Obesity and Prediabetes
NCT06322940 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-12-27
Summary
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.
Conditions
- PreDiabetes
- Overweight and Obesity
Interventions
- OTHER
-
250 mL serving size, 3.25% fat content
Milk
- OTHER
-
175 g serving size, ≥2% fat content
Yogurt
- OTHER
-
50 g serving size, ≥28% fat content
Cheese
Sponsors & Collaborators
-
Dairy Farmers of Canada
collaborator OTHER -
McGill University Health Centre/Research Institute of the McGill University Health Centre
lead OTHER
Principal Investigators
-
Sergio Burgos, PhD · McGill University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-30
- Primary Completion
- 2026-09-01
- Completion
- 2026-12-31
Countries
- Canada
Study Locations
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