Dairy Products for Prediabetes

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how varying amounts of dairy products affect insulin sensitivity in overweight and obese adults with prediabetes. Participants will consume either a limited amount or 2-3 servings of dairy, such as milk, yogurt, or cheese, daily for 12 weeks. The goal is to understand if and how dairy impacts blood sugar control and related health factors. Ideal candidates have maintained stable weight and diet for three months, have a body mass index (BMI) between 25 and 40, and show signs of prediabetes, such as slightly elevated blood sugar levels. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on prediabetes.

Do I need to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants who are on specific medications like diuretics, certain β-blockers, and others that affect glucose metabolism. You also need to temporarily stop taking supplements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that high-fat dairy products like milk, cheese, and yogurt can be safe and might even benefit people with prediabetes.

For regular-fat milk, studies have found a link between increased milk consumption and a lower risk of developing type 2 diabetes. Specifically, high-fat milk has been associated with a better chance of returning to normal blood sugar levels.

Regular-fat cheese is often considered high in saturated fats. However, evidence suggests that cheese, along with other high-fat dairy foods, is linked to a lower risk of prediabetes, making it a potentially safe choice for those with prediabetes.

Regular-fat yogurt also shows promising results. Consuming full-fat yogurt daily has been linked to lower fasting blood sugar levels. Additionally, increased yogurt consumption is associated with a better chance of returning to normal blood sugar levels.

Overall, these dairy products seem to be well-tolerated and may even help manage blood sugar levels in people with prediabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using dairy products like milk, cheese, and yogurt for managing prediabetes because these are everyday foods that could offer a natural way to help balance blood sugar levels. Unlike traditional treatments for prediabetes, which often involve medications or lifestyle changes such as diet and exercise, these dairy products are part of a regular diet and may be easier for people to incorporate into their daily routines. Additionally, the natural fats in these dairy products could have unique benefits for metabolic health that aren't found in low-fat or non-dairy alternatives. This approach could potentially offer a more accessible and enjoyable way for individuals to manage their prediabetes.

What evidence suggests that this trial's dairy product treatments could be effective for prediabetes?

This trial will evaluate the effects of different regular-fat dairy products on insulin handling in people with prediabetes. Participants will be assigned to one of the following treatment arms: 2-3 servings of regular-fat milk, 2-3 servings of regular-fat cheese, or 2-3 servings of regular-fat yogurt. Research has shown that consuming regular-fat dairy products like milk, cheese, and yogurt might improve insulin handling in people with prediabetes. Studies have found that eating high-fat dairy is linked to a 69% higher chance of returning to normal blood sugar levels. Specifically, consuming regular-fat cheese is associated with up to a 14% lower risk of developing prediabetes. For yogurt, having full-fat options daily can help lower fasting blood sugar levels, which benefits prediabetes management. These findings suggest that adding regular-fat dairy to the diet may help control blood sugar more effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

Sergio Burgos, PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

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

Body mass index of 25-40 kg/m2

I am between 30 and 65 years old.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11620717/

The association between consumption of dairy products ... Higher regular fat dairy consumption is associated with lower incidence of metabolic syndrome but not type 2 diabetes. Nutr Metab Cardiovasc ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11004158/

Usual intake of dairy products and the chance of pre- ... Each 200 g/d of high-fat dairy corresponded to an elevated chance of returning to normal glycemia by 69%; higher intakes of high-fat dairy were ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2475299124024041

Dairy Intake in Relation to Prediabetes and Continuous ... Furthermore, total and high-fat cheese were nonlinearly inversely associated with prediabetes risk, with a 14% and 10% lower risk at 2.1 servings/d, ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)04621-4/fulltext

High intake of regular-fat cheese compared with reduced-fat ... A high daily intake of regular-fat cheese for 12 wk did not alter LDL cholesterol or MetS risk factors differently than an equal intake of reduced-fat cheese.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424003376

Dairy consumption and risk of prediabetes and type 2 ... At a mean follow-up of 6.7 ± 2.0 years, 290 participants developed prediabetes (4.3 %). Most dairy products were not significantly associated with prediabetes ...

6. nutrition.org nutrition.org/the-influence-of-diverse-dairy-products-on-prediabetes-disease-risk/

The influence of diverse dairy products on prediabetes ... A higher intake of high-fat dairy, high-fat milk, and total cheese was associated with a lower risk of prediabetes. Low-fat milk intake was ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S095528631830562X

Both low- and regular-fat cheeses mediate improved ... Regular-fat cheese (REG) is often grouped with foods higher in saturated fat that are associated with increased risk of CVD, T2D or MetS, such as red meat [9], ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8026335/

Dairy consumption and risk of type-2 diabetes Higher regular fat dairy consumption is associated with lower incidence of metabolic syndrome but not type 2 diabetes. Nutr Metab Cardiovasc Dis. 2013;23 ...

9. nature.com nature.com/articles/s41387-024-00257-7

Usual intake of dairy products and the chance of pre ... We assessed the possible effect of usual dairy consumption on pre-diabetes (Pre-DM) remission or progression to type 2 diabetes (T2D).

10. dairynutrition.ca dairynutrition.ca/en/nutrition-and-health/diabetes/milk-products-and-type-2-diabetes

Evidence on Milk Products and Type 2 Diabetes Recent evidence suggests that higher-fat milk products, including cheese, may be especially protective in those who have pre-diabetes. Synopsis.