Obesity Clinical Trial
Official title:
Role of Soy for Metabolic Health: The Soy Treatment Evaluation for Metabolic Health (STEM) Trial
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.
Status | Recruiting |
Enrollment | 186 |
Est. completion date | March 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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** |
Country | Name | City | State |
---|---|---|---|
Canada | Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto | United Soybean Board |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ectopic muscle fat | (intra-myocellular lipid [IMCL]) in calf muscles by 1H-MRS measured at weeks 0 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) criteria : waist circumference | Waist circumference measured at weeks 0, 4, 8,12, 16, 20 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) criteria : fasting plasma glucose | Fasting plasma glucose concentration measured at weeks 0 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) criteria - triglycerides | Fasting serum triglycerides concentration measured at weeks 0 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) criteria - HDL cholesterol | Fasting serum HDL cholesterol concentration measured at weeks 0 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) criteria - systolic blood pressure | Systolic blood pressure (SBP) measured at weeks 0, 4, 8,12, 16, 20 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) criteria - diastolic blood pressure | Diastolic blood pressure (DBP) measured at weeks 0, 4, 8,12, 16, 20 and 24 | End value at week 24 | |
Other | Metabolic syndrome (MetS) reversion | Reversion to <3 of 5 IDF/NHLBI/AHA/WHF/IAAS/IASO MetS criteria measured at week 24 | End value at week 24 | |
Other | Diabetes Incidence | Incidence of diabetes (Diabetes Canada 2018 FPG, 2h-PG (75g-OGTT), or HbA1c criteria) measured at week 24 | End value at week 24 | |
Other | body weight | Body weight measured at weeks 0, 4, 8, 12, 16, 20 and 24 | End value at week 24 | |
Other | Microbiome diversity | Gut microbiome composition by 16S rRNA gene sequencing measured at weeks 0 and 24 | End value at week 24 | |
Other | NAFLD markers - ALT | Serum ALT concentrations measured at weeks 0 and 24 | End value at week 24 | |
Other | NAFLD markers - AST | Serum AST concentrations measured at weeks 0 and 24 | End value at week 24 | |
Other | NAFLD markers - GGT | Serum GGT concentrations measured at weeks 0 and 24 | End value at week 24 | |
Other | NAFLD markers - ALP | Serum ALP concentrations measured at weeks 0 and 24 | End value at week 24 | |
Other | NAFLD markers - Fatty liver index (FLI) | Fatty liver index (FLI) measured at weeks 0 and 24 | End value at week 24 | |
Other | Hepatic insulin resistance - HOMA-IR | Homeostatic model assessment of insulin resistance (HOMA IR) measured at weeks 0 and 24 | End value at week 24 | |
Other | Uric acid | Serum uric acid measured at weeks 0 and 24 | End value at week 24 | |
Other | Established lipid targets - LDL Cholesterol | Serum LDL Cholesterol measured at weeks 0 and 24 | End value at week 24 | |
Other | Established lipid targets - non-HDL Cholesterol | Serum non-HDL Cholesterol measured at weeks 0 and 24 | End value at week 24 | |
Other | Established lipid targets - total Cholesterol | Serum total Cholesterol measured at weeks 0 and 24 | End value at week 24 | |
Other | Inflammation - high sensitivity C-reactive protein (hs-CRP) | Serum high sensitivity C-reactive protein (hs-CRP) measured at weeks 0 and 24 | End value at week 24 | |
Other | Kidney function/injury - creatinine | Serum creatinine measured at weeks 0 and 24 | End value at week 24 | |
Other | Kidney function/injury - eGFR | eGFR measured at weeks 0 and 24 | End value at week 24 | |
Other | Kidney function/injury - urinary albumin excretion rate (AER) | Urinary AER measured from a 24 hour urine collection at weeks 0 and 24 | End value at week 24 | |
Other | Diet quality - Alternative Healthy Eating Index (AHEI) | The Alternative Healthy Eating Index (AHEI) is comprised of 10 food components with each component scored on a 0 to 10 point scale and summed. where 0 is the lowest and 100 is the highest total score. Assessments will be done measured at weeks 0 and 24. | End value at week 24 | |
Other | Appetite | Appetite assessed by Control of Eating Questionnaire (CoEQ). The CoEQ comprises 21 items related to six sections: appetite, craving control, craving for sweet, craving for savoury, positive mood, perceived control over resisting a specific craved food. Items are assessed using 100-mm visual analogue scales, where 0 mm is lowest and 100 mm is highest. Assessments will be done at weeks 0, 4, 8, 12, 16, 20 and 24. | End value at week 24 | |
Other | Food craving control | Food craving control assessed by Control of Eating Questionnaire (CoEQ). The CoEQ comprises 21 items related to six sections: appetite, craving control, craving for sweet, craving for savoury, positive mood, perceived control over resisting a specific craved food. Items are assessed using 100-mm visual analogue scales, where 0 mm is lowest and 100 mm is highest. Assessments will be done at weeks 0, 4, 8, 12, 16, 20 and 24. | End value at week 24 | |
Other | Food craving for savoury | Food craving for savoury assessed by Control of Eating Questionnaire (CoEQ). The CoEQ comprises 21 items related to six sections: appetite, craving control, craving for sweet, craving for savoury, positive mood, perceived control over resisting a specific craved food. Items are assessed using 100-mm visual analogue scales, where 0 mm is lowest and 100 mm is highest. Assessments will be done at weeks 0, 4, 8, 12, 16, 20 and 24. | End value at week 24 | |
Other | Food craving for sweet | Food craving for sweet assessed by the Control of Eating Questionnaire (CoEQ). The CoEQ comprises 21 items related to six sections: appetite, craving control, craving for sweet, craving for savoury, positive mood, perceived control over resisting a specific craved food. Items are assessed using 100-mm visual analogue scales, where 0 mm is lowest and 100 mm is highest. Assessments will be done at weeks 0, 4, 8, 12, 16, 20 and 24. | End value at week 24 | |
Other | Perceived craving control over SSBs | Perceived craving control over SSBs assessed by the Control of Eating Questionnaire (CoEQ). The CoEQ comprises 21 items related to six sections: appetite, craving control, craving for sweet, craving for savoury, positive mood, perceived control over resisting a specific craved food. Items are assessed using 100-mm visual analogue scales, where 0 mm is lowest and 100 mm is highest. Assessments will be done at weeks 0, 4, 8, 12, 16, 20 and 24. | End value at week 24 | |
Other | Positive mood | Positive Mood assessed by Control of Eating Questionnaire (CoEQ). The CoEQ comprises 21 items related to six sections: appetite, craving control, craving for sweet, craving for savoury, positive mood, perceived control over resisting a specific craved food. Items are assessed using 100-mm visual analogue scales, where 0 mm is lowest and 100 mm is highest. Assessments will be done at weeks 0, 4, 8, 12, 16, 20 and 24. | End value at week 24 | |
Other | Adherence markers - Beverage logs | Adherence by self-report beverage logs measured at weeks 0, 4, 8, 12, 16, 20 and 24 | End value at week 24 | |
Other | Adherence biomarkers - Objective biomarker of soy milk | Urinary isoflavonones excretion [UIE] measured at weeks 0, 12, and 24. | End value at week 24 | |
Other | Adherence biomarkers - Objective biomarkers of cow's milk | Dairy-derived serum fatty acids [15:0, 17:0, conjugated linoleic acid, trans-palmitoleic acid] measured at weeks 0, 12, and 24. | End value at week 24 | |
Other | Adherence biomarkers - Objective biomarkers of SSBs (13C/12C ratios in serum fatty acids) | 13C/12C ratios in serum fatty acids measured at weeks 0, 12, and 24. | End value at week 24 | |
Other | Adherence biomarkers - Objective biomarkers of SSBs (urinary fructose) | urinary fructose measured at weeks 0, 12, and 24. | End value at week 24 | |
Primary | Liver fat | intra-hepatocellular lipid (IHCL) by 1H-MRS measured at weeks 0 and 24 | End value at week 24 | |
Secondary | Whole body insulin sensitivity | 75g OGTT derived Matsuda whole body insulin sensitivity index (Matsuda ISI) at weeks 0 and 24 | End value at week 24 | |
Secondary | Beta-cell function | 75g OGTT derived insulin secretion-sensitivity index-2 (ISSI-2) measured at weeks 0 and 24 | End value at week 24 | |
Secondary | Glucose tolerance - plasma glucose AUC | 75g OGTT derived plasma glucose area under the curve (AUC) measured at weeks 0 and 24 | End value at week 24 | |
Secondary | Glucose tolerance - 2-hour plasma glucose (2h-PG) | 75g OGTT derived 2-hour plasma glucose (2h-PG) measured at weeks 0 and 24 | End value at week 24 |
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