Soy Milk for Metabolic Health

Overseen By Sonia Blanco Mejia, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Diabetes, Hypertension, Liver disease, others

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

Compensation: Varies

Number of Visits: 9

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether replacing sugary drinks with soy milk can improve metabolic health, addressing issues like obesity and diabetes. Participants will switch to drinking 2% soy milk, 2% cow's milk, or continue with their usual sugary drinks. The trial aims to determine if soy milk provides benefits similar to cow's milk, such as reducing weight, decreasing liver fat, and improving heart health markers. Suitable participants have a high waist circumference, are overweight, and regularly consume sugary beverages. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to healthier lifestyle recommendations.

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

The trial requires that if you are taking any medications, they must be at a stable dose for at least 6 months before participating. There is no mention of needing to stop any current medications.

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

Research has shown that soy milk is generally safe for most people. One study found that drinking soy milk can improve heart health by lowering cholesterol levels. This suggests that soy milk is usually well-tolerated and can be a healthy part of a diet.

Another report confirmed that soy promotes health, particularly in preventing high cholesterol and heart disease. While soy is considered safe, some people might experience minor digestive issues, like gas or bloating, but these are usually not serious. Overall, soy milk is considered safe, making it a good choice for those interested in joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using soy milk for metabolic health because it offers a plant-based alternative to traditional options like cow's milk, which could be beneficial for those with lactose intolerance or who follow a vegan diet. Soy milk is rich in bioactive compounds such as isoflavones, which may aid in improving metabolic markers like blood sugar and cholesterol levels. Unlike sugar-sweetened beverages that can contribute to metabolic issues, substituting them with soy milk could provide a healthier beverage choice that supports overall metabolic health.

What evidence suggests that soy milk might be an effective treatment for metabolic health?

This trial will compare the effects of substituting regular sugar-sweetened beverages with either 2% cow's milk or 2% soy milk. Studies have shown that switching from cow's milk to soy milk benefits heart and overall health. Research indicates that drinking soy milk can lower both systolic and diastolic blood pressure, reducing the heart's workload. It also helps reduce total and bad cholesterol levels, which are linked to heart disease. Some studies found that soy milk can aid in weight management by reducing waist size and body fat. These benefits suggest that soy milk might be a healthy choice for those looking to improve heart and metabolic health. ^{3 4 6 7 8}

Who Is on the Research Team?

John Sievenpiper, MD,PhD,FRCPC

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

The STEM trial is for adults aged 18-75 who are overweight or obese with a BMI of 27-45 and have metabolic syndrome, including high waist circumference and dysglycemia. Participants should be regular consumers of sugar-sweetened beverages but not smokers or users of certain medications that affect the study's outcomes. Pregnant women, those planning dietary changes, and individuals with various health conditions like uncontrolled thyroid issues or recent major surgery are excluded.

Inclusion Criteria

I am overweight or obese with MetS, including high waist size and blood sugar.

You drink sugary drinks like sodas, sweetened teas, or energy drinks three or more times a day.

Exclusion Criteria

I have cystic fibrosis.

I have been diagnosed with polycystic ovarian syndrome.

I have a long-term lung condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Run-in

Participants undergo a run-in phase to ensure adherence before randomization

4 weeks

1 visit (in-person)

Treatment

Participants are randomized to replace SSBs with either 2% soy milk, 2% cow's milk, or continue with SSBs

24 weeks

6 visits (in-person, every 4 weeks)

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

• Cow's Milk
• Soy Milk
• Sugar Sweetened Beverages

Trial Overview This trial tests whether replacing sugar-sweetened beverages with soy milk instead of cow's milk can improve liver fat levels and other indicators related to obesity and diabetes. It's a randomized controlled trial comparing the effects of using 2% soy milk versus 2% cow's milk in an at-risk population.

How Is the Trial Designed?

Group I: 2% Cow's Milk Active Control 1 Intervention

Participants will be asked to substitute their regular sugar sweetened beverage with the 2% cow's milk (up to a maximum of 6 servings/day)

Group II: 2% Soy Milk Active Control 1 Intervention

Participants will be asked to substitute their regular sugar sweetened beverage with the 2% soy milk (up to a maximum of 6 servings/day)

Group III: Usual Sugar Sweetened Beverage Active Control 1 Intervention

Participants will be asked to continue drinking their regular sugar sweetened beverage

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

United Soybean Board

Collaborator

Trials

2

Recruited

270+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5188409/

Soy and Health Update: Evaluation of the Clinical and ... In addition, soy alleviates hot flashes and may favorably affect renal function, alleviate depressive symptoms and improve skin health. Much of the focus on ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11340166/

A systematic review and meta-analysis of randomized trials of ... A systematic review and meta-analysis of randomized trials of substituting soymilk for cow's milk and intermediate cardiometabolic outcomes

3. sciencedirect.com sciencedirect.com/science/article/pii/S1756464621001481

Impact of soy milk consumption on cardiometabolic risk ... The quantitative meta-analysis demonstrated that soy milk consumption significantly reduced systolic and diastolic blood pressure, total and low-density ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322008031

Effect of Soy and Soy Isoflavones on Obesity-Related ... We conducted this meta-analysis to evaluate potential effects of soy and soy isoflavones on weight, waist circumference, and fat mass.

5. soyconnection.com soyconnection.com/continuing-education/education-credits/newsletter-article-list/exploring-soymilk-and-cardiometabolic-health-a-systematic-review-and-meta--analysis

EXPLORING SOYMILK AND CARDIOMETABOLIC HEALTH Available outcome data included LDL cholesterol (6 trials), HDL cholesterol (4 trials), non-HDL cholesterol (3 trials), triglycerides (4 trials), HbA1c (1 trial) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192877/

Effects of soy consumption on metabolic parameters in ... Consuming soy products in patients with MetS effectively improved lipid profile and glycemic parameters independent of affecting anthropometric measures.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9410752/

The health effects of soy: A reference guide for ... On the other hand, in 2015, the EFSA concluded isoflavone supplements (soyfoods were not examined) do not affect breast tissue in postmenopausal women (109).

8. webmd.com webmd.com/vitamins/ai/ingredientmono-975/soy

Soy - Uses, Side Effects, and More Eating soy protein products helps lower blood sugar levels and improve other measures of the disease in people with metabolic syndrome. Muscle strength. Taking ...