The Soy Treatment Evaluation for Metabolic Health (STEM) Trial
Metabolic Syndrome, Overweight and Obesity, PreDiabetes
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Microbiome, Soy milk, Soy beverage, Cow's milk, Dairy, Sugar sweetened beverages, Glucose response, Metabolic health
Eligibility Criteria
Inclusion Criteria:
- Adults (age 18-75 years), men and non-pregnant women
- Overweight or obese (BMI 27-45 kg/m2) with MetS based on modified
- Modified IDF/NHLBI/AHA/WHF/IAAS/IASO criteria: high waist circumference (≥88cm females, ≥102cm males) and dysglycemia (fasting plasma glucose [FPG] ≥5.6 - 6.9mmol/L), plus ≥1 of the 3 remaining criteria (High triglycerides (≥1.7mmol/L), Low HDL-C (<1.0mmol/L males and <1.3 mmol/L females), High blood pressure (≥ 130/85mmHg)
- Regularly drinking SSBs (≥ 3 servings/day))
Exclusion Criteria:
- Diabetes mellitus
- cow's milk or soy intolerance or allergy
- Pregnant or breast-feeding females, or women planning on becoming pregnant throughout the study period
- Weight loss of ≥10% in the last 6 months
- Severe uncontrolled hypertension (or systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg)
- Polycystic ovarian syndrome
- Atherosclerotic cardiovascular disease (ASCVD)
- Coeliac's disease
- Wilson's disease
- Haemochromatosis
- Inborn errors of metabolism
- Lipodystrophy
- Cushing syndrome or disease
- Gastrointestinal disease (inflammatory bowel disease or malabsorption disorder)
- Alcoholic fatty liver disease; cirrhosis; hepatocellular carcinoma; HCV, HBV, or HAV infection; or genetic causes of liver disease (Alpha-1-antitrypsin [A1A] deficiency)
- Uncontrolled hyperthyroidism or hypothyroidism
- Acute kidney injury (AKI) or high risk or very high risk chronic kidney disease (CKD) (KIDIGO 2012 criteria)
- Acute or chronic infection (e.g. active COVID-19, salmonellosis, HIV, TB)
- Chronic inflammatory conditions
- Chronic lung disease
- Chronic pancreatitis or pancreatic insufficiency
- Cystic fibrosis
- Polycystic ovarian syndrome (PCOS)
- Cancer/malignancy in the last 6 months, with the exception of skin cancer
- Colectomy or small bowel resection
- Bariatric surgery
- Major surgery in the last 6 months
- Schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders
- Severe depression
- Hypopituitarism
- Hypogonadism
- Other major illness or health-related disease
- Habitual tobacco smoker
- Habitual recreational drug users
- Heavy alcohol use (>3 drinks/day)
- Participation in any trials within the last 3 months or for the duration of this study
- Any contraindication to MRI (e.g. pacemaker, neurostimulators, breast tissue expanders, implants, foreign metal object in body, or claustrophobia)
- Individuals planning on making dietary or physical activity changes throughout study duration
- Medication use that can affect the primary and secondary outcomes such as oral corticosteroids, any antihyperglycemic medications (including pioglitazone), amiodarone, methotrexate, valproic acid, highly active antiretroviral therapy (HAART) for HIV, total parenteral nutrition (TPN), atypical antipsychotics [clozapine olanzapine, risperidone], high dose vitamin E supplements (does not include multivitamins), L-carnitine supplements, or any other deemed as inappropriate by investigators.)
- Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators
**Disease exclusions will be based upon self-reported diagnosis**
Sites / Locations
- Clinical Nutrition and Risk Factor Modification Centre, St. Michael's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
2% Soy Milk
2% Cow's Milk
Usual Sugar Sweetened Beverage
Participants will be asked to substitute their regular sugar sweetened beverage with the 2% soy milk (up to a maximum of 6 servings/day)
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)
Participants will be asked to continue drinking their regular sugar sweetened beverage