Dairy Products for Prediabetes

Overseen By Sergio Burgos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must not be taking: Diuretics, β-blockers, Bronchodilators, others

Disqualifiers: Smoking, Pregnancy, Dairy allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sergio Burgos, PhD

Principal Investigator

McGill University

Eligibility Criteria

This trial is for overweight or obese adults aged 30-65 in the Montreal area with prediabetes. Participants must be willing to consume regular-fat dairy during a run-in period and then either limited, reduced-fat, or regular-fat dairy daily for 12 weeks.

Inclusion Criteria

I am between 30 and 65 years old.

Body mass index of 25-40 kg/m2

Stable weight and dietary habits over a period of 3 months

Exclusion Criteria

Inaccessible veins

Breastfeeding

I am taking medication that affects my blood sugar levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants consume 1 serving/day of regular-fat dairy products for 2 weeks

2 weeks

1 visit (in-person)

Treatment

Participants are randomized into groups to consume 2-3 servings/day of dairy products for 12 weeks

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Dairy Product Matrices

Trial Overview The study aims to see how different amounts and types of dairy (milk, yogurt, cheese) affect insulin sensitivity in participants. They'll be divided into groups by sex and assigned varying dairy servings per day for comparison.

Participant Groups

Group I: 2-3 servings of regular-fat yogurt Experimental Treatment 1 Intervention

Yogurt

Group II: 2-3 servings of regular-fat milk Experimental Treatment 1 Intervention

Milk

Group III: 2-3 servings of regular-fat cheese Experimental Treatment 1 Intervention

Cheese

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Dairy Farmers of Canada

Collaborator

Trials

33

Recruited

2,400+