Full-fat Dairy Products for Obesity

Not currently recruiting at 1 trial location

Overseen By Marisa Soo, MSc. (C)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Blood glucose drugs

Disqualifiers: Cardiovascular, Diabetes, Liver, Kidney, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how full-fat dairy and various eating habits affect weight and heart health in overweight individuals. Participants will follow one of three diets: an energy-restricted diet with full-fat dairy, a low-dairy energy-restricted diet, or a normal diet with full-fat dairy. The trial seeks individuals who are overweight, rarely consume dairy, and are willing to maintain their usual diet and exercise habits during the study. As an unphased trial, it offers a unique opportunity to contribute to understanding the impact of dietary habits on health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take any drugs or supplements that affect blood glucose or could impact the study's results.

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

Research shows that full-fat dairy products can be safely included in a diet. Studies have found that consuming whole dairy foods, such as milk, yogurt, and cheese, does not lead to weight gain or heart problems when part of a regular diet. In fact, some research suggests that full-fat dairy might help reduce obesity rates.

Despite being high in saturated fats, full-fat dairy does not appear to increase the risk of heart disease. Observational studies have not found a link between dairy fat and weight gain or heart health issues. Instead, full-fat dairy products may actually lower the risk of becoming overweight or obese.

For those considering joining a study involving full-fat dairy consumption, the safety data appears promising. Full-fat dairy products are generally well-tolerated and have not been linked to major health issues in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for obesity because they explore the potential benefits of full-fat dairy products, which aren't typically highlighted in weight loss strategies. Unlike standard low-fat diets or calorie counting, one treatment approach combines three servings of full-fat dairy with a calorie-restricted diet, which could offer a unique balance of satiation and energy control. Another approach includes these servings without any calorie restriction, providing insights into how full-fat dairy might contribute to weight management on its own. These treatments challenge conventional low-fat dietary guidelines and could reshape our understanding of how full-fat dairy impacts body weight and health.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare different dietary approaches involving full-fat dairy products and energy restriction. Research has shown that full-fat dairy products might aid in weight control. Studies have found a link between drinking whole milk and lower body weight and a healthier body mass index (BMI). A review of several studies showed a small reduction in body fat for those who consume more dairy. Additionally, some research suggests that the saturated fat in whole-milk dairy foods can improve body composition, even without weight loss. These findings suggest full-fat dairy could help manage obesity and improve overall health. ^{6 7 8 9 10}

Who Is on the Research Team?

G. Harvey Anderson, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for healthy overweight/obese adults with a BMI between 27 and 34.9, normal fasting glucose levels, and low dairy consumption. Participants should maintain their usual diet and activity level but avoid alcohol before test visits. Exclusions include irregular menstrual cycles, certain metabolic disorders, extreme diets, substance use, recent significant weight changes or history of childhood obesity.

Inclusion Criteria

Your body mass index (BMI) is between 27 and 34.9.

Fasting serum glucose: ≤ 7 mmol/L

Willing to avoid vigorous physical activity for 24 h prior to all test visits.

Exclusion Criteria

Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal

People who have a history of trying to limit their food intake in an unhealthy way.

Fasting blood glucose > 7 mmol/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a diet modification with or without full-fat dairy products or restrictive eating for 12 weeks

12 weeks

8 sessions biweekly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 session

What Are the Treatments Tested in This Trial?

Interventions

• Full-fat Dairy Products
• Restrictive Eating

Trial Overview The study examines the impact of long-term dietary changes on body weight and health markers in overweight individuals. It compares effects of including full-fat dairy products versus restrictive eating without these products on satiety, body composition, and blood sugar control.

How Is the Trial Designed?

Group I: Low Dairy Energy Restrictive Diet Experimental Treatment 1 Intervention

Low-dairy (\<1 serving/day) and 500kcal/deficit per day energy restrictive diet

Group II: 3 Servings of Full-Fat Dairy with Energy Restrictive diet Experimental Treatment 2 Interventions

Energy-restrictive diet (500 kcal/deficit per day) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Group III: 3 Servings of Full-Fat Dairy but no energy restriction Experimental Treatment 1 Intervention

Normal diet (no energy restriction) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Mount Saint Vincent University

Collaborator

Trials

23

Recruited

2,300+

Published Research Related to This Trial

In a study of 46 very obese individuals (11 inpatients and 35 outpatients), it was found that their caloric intake was directly related to their level of obesity, with both groups consuming high-calorie density foods and engaging in occasional binge eating.

By replacing high-calorie density foods with lower-calorie options, participants could potentially reduce their caloric intake by 20%, which could significantly aid in weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food intake of very obese persons: quantitative and qualitative aspects. Strain, GW., Hershcopf, RJ., Zumoff, B.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3441106/

Effects of dairy intake on body weight and fat: a meta-analysis ... Twenty-two RCTs that reported results on body fat showed a modest reduction in the dairy group (−0.45 kg; 95% CI: −0.79, −0.11 kg; I2 = 70.9%), and further ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0271531724001453

Whole milk intake is associated with lower body weight and ... The results indicate that whole milk intake was inversely associated with weight, BMI and prevalence of obesity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10459826/

The Relationship between Whole-Milk Dairy Foods and ... The study demonstrated that saturated fat contained in whole-milk dairy foods improved body composition in the absence of weight loss [29].

4. news-medical.net news-medical.net/news/20241120/Rethinking-dairy-Whole-milk-tied-to-healthier-weight-profiles.aspx

Rethinking dairy: Whole milk tied to healthier weight profiles The findings suggest that whole milk may be beneficial in healthier body weight profiles and reduced central obesity risk, challenging the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004355

Dairy Foods, Obesity, and Metabolic Health: The Role of ... Dairy consumption led to a reduction in fat mass (0.23 kg) and an increase in lean body mass (0.37 kg). Overall, high-dairy intervention increased body weight ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6014779/

The dairy fat paradox: Whole dairy products may be healthier ... The dairy fat paradox suggests that dairy fat intake is not linked to higher risks of weight gain, CVD, or type II diabetes, unlike low-fat recommendations.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9776648/

Consumption of Dairy Products and the Risk of Overweight ... For overweight or obesity, a linear association was observed for total dairy, milk, and yogurt. The risk decreased by 25%, 7%, and 12% per 200-g/d increase for ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522005342

Whole-fat dairy products do not adversely affect adiposity ... Observational studies of adults show that dairy fat is not commonly associated with weight gain or cardiometabolic dysfunction when consumed as part of typical ...

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1386257/full

Full-fat dairy products and cardiometabolic health outcomes Whole-fat dairy food intake is inversely associated with obesity prevalence: findings from the observation of cardiovascular risk factors in Luxembourg study.

10. mcpress.mayoclinic.org mcpress.mayoclinic.org/dairy-health/full-fat-dairy-foods-and-cardiovascular-disease-is-there-a-connection/

Full-fat dairy foods and cardiovascular disease: Is there a ... The analysis showed that despite being a major dietary source of saturated fats, full-fat dairy consumption was not associated with the risk of ...