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ACTIVE NOT RECRUITING

NCT05191160

The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Sponsor: University of Toronto

View on ClinicalTrials.gov

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.

Official title: Role of Soy for Metabolic Health: The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2021-11-02

Completion Date

2025-03-30

Last Updated

2024-04-18

Healthy Volunteers

Yes

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

Inclusion Criteria: * 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)) Exclusion Criteria: * 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 * Self-reported gastrointestinal disease (inflammatory bowel disease or malabsorption disorder) * Previous bariatric surgery * Self-reported alcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma, HCV, HBV, or HAV infection, or genetic causes of liver disease (Alpha-1-antitrypsin \[A1A\] deficiency) * Self-reported uncontrolled hyperthyroidism or hypothyroidism * Self-reported high risk or very high risk chronic kidney disease (CKD) (KIDIGO 2012 criteria) * Self-reported acute or chronic infection (e.g. salmonellosis, HIV, TB) * Self-reported chronic inflammatory conditions * Self-reported chronic lung disease * Self-reported chronic pancreatitis or pancreatic insufficiency * Self-reported cystic fibrosis * Self-reported cancer/malignancy in the last 6 months, with the exception of skin cancer * Self-reported schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders * Self-reported severe depression * Self-reported major surgery in the last 6 months * Self-reported hypopituitarism * Self-reported hypogonadism * Self-reported substance abuse disorder (substance dependence including alcohol or recreational drugs) * Participation in any trials within the last 3 months or for the duration of this study * Any condition or circumstance which would prevent you from having an MRI (e.g. pacemaker, neurostimulators, breast tissue expanders, implants, or foreign metal object in body) * Individuals planning on making dietary or physical activity changes throughout study duration * If self-reported medication use, it must be at a stable dose for ≥6 months. \*\*Disease exclusions will be based upon self-reported diagnosis\*\*

Locations (1)

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

Toronto, Ontario, Canada

Clinical Research Directory

The Soy Treatment Evaluation for Metabolic Health (STEM) Trial

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)