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

186 Participants Needed

Trial Summary

What is the purpose of this trial?

Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.

Research Team

John Sievenpiper, MD,PhD,FRCPC

Principal Investigator

University of Toronto

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+