The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

NCT05191160 | Active Not Recruiting

• 1 other identifier: USB/USDA - STEM trial
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiome; Soy milk; Soy beverage; Cow's milk; Dairy; Sugar sweetened beverages; Glucose response; Metabolic health

Outcome Measures

Primary Outcomes (1)

• Liver fat

  intra-hepatocellular lipid (IHCL) by 1H-MRS measured at weeks 0 and 24

  End value at week 24

Secondary Outcomes (4)

• Whole body insulin sensitivity

  End value at week 24

• Beta-cell function

  End value at week 24

• Glucose tolerance - plasma glucose AUC

  End value at week 24

• Glucose tolerance - 2-hour plasma glucose (2h-PG)

  End value at week 24

Other Outcomes (37)

• Ectopic muscle fat

  End value at week 24

• Metabolic syndrome (MetS) criteria : waist circumference

  End value at week 24

• Metabolic syndrome (MetS) criteria : fasting plasma glucose

  End value at week 24

Study Arms (3)

2% Soy Milk

ACTIVE COMPARATOR

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

Other: Soy Milk

2% Cow's Milk

ACTIVE COMPARATOR

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)

Other: Cow's Milk

Usual Sugar Sweetened Beverage

ACTIVE COMPARATOR

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

Other: Sugar Sweetened Beverages

Interventions

Soy Milk OTHER

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

2% Soy Milk

Cow's Milk OTHER

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

2% Cow's Milk

Sugar Sweetened Beverages OTHER

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

Usual Sugar Sweetened Beverage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18-75 years), men and non-pregnant women
• Overweight or obese (≥ 25 kg/m2)
• High waist circumference (USA/Canada ≥102cm in men, ≥88cm in women; Europid/Caucasian/Middle East, Mediterranean/Sub-Saharan African ≥94cm in men, ≥80cm in women; and Asian \[including Japanese\]/Ethnic Central and South American ≥90cm in men, ≥80cm in women\[37\], with a waist diameter ≤60 cm)
• Regularly drinking SSBs (≥ 1 servings/day))

You may not qualify if:

• Age \<18 or \>75 years.
• BMI \<25.
• Waist circumference lower than threshold\[37\] (USA/Canada \<102cm in men, \<88cm in women; Europid/Caucasian/Middle East, Mediterranean/Sub-Saharan African \<94cm in men, \<80cm in women; and Asian \[including Japanese\]/Ethnic Central and South American \<90cm in men, \<80cm in women) or a waist diameter \>60cm.
• Uncontrolled hypertension (or systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg
• Self-reported diabetes
• Not regularly drinking SSBs (\<1 serving per day)
• Self-reported cow's milk or soy intolerance or allergy
• Self-reported pregnant or breast-feeding females, or women planning on becoming pregnant throughout the study period
• Self-reported weight loss of ≥10% in the last 6 months
• Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators
• Self-reported Wilson's disease
• Self-reported haemochromatosis
• Self-reported inborn errors of metabolism
• Self-reported lipodystrophy
• Self-reported Cushing syndrome or disease

Sponsors & Collaborators

• University of Toronto: lead
• United Soybean Board: collaborator

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Obesity; Prediabetic State; Diabetes Mellitus; Obesity, Metabolically Benign; Cardiovascular Diseases; Hypertension; Dyslipidemias

Interventions

Soy Milk; Milk; Sugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Vascular Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food; Food and Beverages; Dairy Products

Study Officials

• John Sievenpiper, MD,PhD,FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the participants and investigators will not be possible due to packaging, taste and look of the interventions. However, outcome assessors (laboratory, microbiome analysis) and the statistician will be blinded to the identity of the treatments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2-phase, 3-arm, non-inferiority, open-label, parallel group, randomized controlled trial

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: January 13, 2022
• Study Start: November 2, 2021
• Primary Completion: October 30, 2024
• Study Completion: March 30, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)