Status:
ACTIVE_NOT_RECRUITING
The Soy Treatment Evaluation for Metabolic Health (STEM) Trial
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
United Soybean Board
Conditions:
Metabolic Syndrome
Overweight and Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
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 policie...
Detailed Description
Rationale: Soy is at a nutritional "cross-roads". On one hand, it aligns with current dietary advice to consume plant-based dietary patterns \[1-6\] and has proven advantages \[7-9\]. On the other ha...
Eligibility Criteria
Inclusion
- 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
- 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\*\*
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05191160
Start Date
November 2 2021
End Date
March 30 2025
Last Update
April 18 2024
Active Locations (1)
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1
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2