The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Summary

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.

Conditions

• Metabolic Syndrome
• Overweight and Obesity
• PreDiabetes
• Diabetes
• Healthy Obesity, Metabolically
• Overweight
• Obesity
• Dysglycemia
• Cardiovascular Diseases
• Heart Disease Risk Factors
• Hypertension
• Dyslipidemias

Interventions

OTHER

Soy Milk

250 mL, single-serve shelf-stable pack (Alpro Soya) 100 Kcal, 8g of soy protein

OTHER

Cow's Milk

250 mL, single-serve shelf-stable pack (Organic Meadows) 130 Kcal, 8g of casein/whey protein

OTHER

Sugar Sweetened Beverages

355 mL, single-serve cans 130-140 Kcal, 0g of protein

Sponsors & Collaborators

• United Soybean Board

  collaborator UNKNOWN

• University of Toronto

  lead OTHER

Principal Investigators

• John Sievenpiper, MD,PhD,FRCPC · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-02

Primary Completion

2024-10-30

Completion

2025-03-30

Countries

• Canada

Study Locations