CompletedNot Applicable

Effect of Dairy Products on Insulin Resistance

Canada60 participantsStarted 2022-06-10

Plain-language 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 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.

Who can participate

Age range

30 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in whole-body insulin sensitivity

Timeframe: Difference between baseline and 12-weeks intervention visit

Trial details

NCT IDNCT05421390

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-18

View on ClinicalTrials.gov More Insulin Sensitivity trials

Plain-language summary