{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T16:36:45Z","timestamp":1778690205173,"version":"3.51.4"},"reference-count":129,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T00:00:00Z","timestamp":1774310400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012009","name":"United Soybean Board","doi-asserted-by":"crossref","award":["2030-262-0419"],"award-info":[{"award-number":["2030-262-0419"]}],"id":[{"id":"10.13039\/100012009","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100012009","name":"United Soybean Board","doi-asserted-by":"crossref","award":["2230-262-0412"],"award-info":[{"award-number":["2230-262-0412"]}],"id":[{"id":"10.13039\/100012009","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100012009","name":"United Soybean Board","doi-asserted-by":"crossref","award":["2311-108-0101"],"award-info":[{"award-number":["2311-108-0101"]}],"id":[{"id":"10.13039\/100012009","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100012009","name":"United Soybean Board","doi-asserted-by":"crossref","award":["2411-108-0101"],"award-info":[{"award-number":["2411-108-0101"]}],"id":[{"id":"10.13039\/100012009","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100010710","name":"Dairy Farmers of Canada","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100010710","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Nutrition Trialists Network Fund"},{"name":"Plant Milk Fund"},{"name":"The Canada Foundation for Innovation (CFI) and the Ministry of Research and Innovation\u2019s Ontario Research Fund","award":["37544"],"award-info":[{"award-number":["37544"]}]},{"name":"The Canada Foundation for Innovation (CFI) and the Ministry of Research and Innovation\u2019s Ontario Research Fund","award":["492343"],"award-info":[{"award-number":["492343"]}]},{"name":"CIHR Canadian Graduate Scholarship Doctoral Award"},{"name":"Toronto 3D PhD Scholarship"},{"name":"Undergraduate Summer Research Opportunity Program"},{"name":"Toronto 3D Summer Scholarship Top-up Award"},{"name":"Toronto 3D Supper Scholarship Award"},{"name":"CIHR Canadian Graduate Scholarship Masters Award"},{"DOI":"10.13039\/501100001804","name":"Canada Research Chairs Program","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100001804","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Toronto 3D New Investigator Award"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Background\/Objectives: Liver fat represents an early metabolic lesion in the development of diabetes and its cardiometabolic complications. Diets high in free sugars, particularly from sugar-sweetened beverages (SSBs), are associated with abdominal obesity and increased cardiometabolic risk, prompting global guidelines to limit SSBs as a major public health strategy. Low-fat cow\u2019s milk is promoted as the preferred caloric replacement strategy for SSBs due to its high nutritional value and cardiometabolic advantages. Fortified soymilk is a plant-based alternative with approved health claims for cholesterol and coronary heart disease risk reduction that offers an equivalent nutritional value to cow\u2019s milk. However, given concerns about its classification as an ultra-processed food (UPF), it is unclear whether soymilk offers comparable metabolic health benefits to milk as part of clinical and public health strategies to reduce SSB intake. The Soy Treatment Evaluation for Metabolic (STEM) health trial seeks to evaluate the impact of replacing SSBs with either 2% soymilk or 2% cow\u2019s milk on liver fat and other cardiometabolic risk factors in habitual adult consumers of SSBs with obesity. Methods: The STEM trial is a 24-week, pragmatic, 3-arm, parallel, randomized trial. We recruited adults with obesity (high BMI plus high waist circumference based on ethnic specific cut-offs) consuming \u22651 SSB\/day. Participants were randomized to one of three groups based on their usual SSB intake at baseline (servings\/day): continued SSB (355 mL can) intake; replacement with fortified, sweetened 2% soymilk (250 mL); or replacement with 2% cow\u2019s milk (250 mL). The primary outcome is the change in intrahepatocellular lipid (IHCL) measured by 1H-MRS at 24 weeks. Hierarchical testing will be done to reduce the familywise error rate. The superiority of cow\u2019s milk to SSBs will be assessed first to establish assay sensitivity. If superiority is established, then the non-inferiority of soymilk to cow\u2019s milk will be assessed using a pre-specified non-inferiority margin of 1.5% IHCL units (assessed by difference of means using a 90% confidence interval [CI]). Analyses will be conducted according to the intention-to-treat (ITT) principle using inverse probability weighting (IPW) for superiority testing and per-protocol analyses for non-inferiority testing, using ANCOVA adjusted for age, sex, metabolic dysfunction-associated steatotic liver disease (MASLD) status, medication use, intervention dose, and baseline levels. We hypothesize that soymilk will be non-inferior to cow\u2019s milk (Clinicaltrials.gov NCT05191160). Results: Recruitment began in November 2021. A total of 3050 individuals were screened. We randomized 186 participants (62 per group) between 19 April 2022 and 16 April 2024. Participants are 57% male; with a mean [SD] age of 39.9 [11.8] years; BMI of 34.6 [6.1] kg\/m2, waist circumference of 112.6 [13.8] cm; IHCL of 10.0 [8.2] % with 64.1% meeting the criteria for MASLD; and SSBs intake of 2.3 [1.3] servings\/day. Conclusions: Baseline characteristics were balanced across the study arms, with participants representing adults with a high-risk metabolic phenotype, and 64.1% meeting the criteria for MASLD. Findings will contribute to evidence on the cardiometabolic benefits of soymilk, informing clinical practice guidelines and public health policy.<\/jats:p>","DOI":"10.3390\/nu18071026","type":"journal-article","created":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T09:11:14Z","timestamp":1774429874000},"page":"1026","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Rationale, Design, and Participant Baseline Characteristics of a Parallel Randomized Trial of the Effect of Replacing SSBs with Cow\u2019s Milk Versus Soymilk on Intrahepatocellular Lipid and Other Cardiometabolic Risk Factors in Adults with Obesity Who Consume Sugar-Sweetened Beverages: The Soy Treatment Evaluation for Metabolic health (STEM) Trial"],"prefix":"10.3390","volume":"18","author":[{"given":"Madeline N.","family":"Erlich","sequence":"first","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2477-9758","authenticated-orcid":false,"given":"Diana","family":"Ghidanac","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4199-1800","authenticated-orcid":false,"given":"Sonia","family":"Blanco Mejia","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7087-7815","authenticated-orcid":false,"given":"Sabrina","family":"Ayoub-Charette","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Vittes Combe","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3713-2248","authenticated-orcid":false,"given":"Tauseef A.","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Devina","family":"Ramdath","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Crewson","sequence":"additional","affiliation":[{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"Department of Family Relations and Applied Nutrition, University of Guelph, Guelph, ON N1G 2W1, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Beck","sequence":"additional","affiliation":[{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"Clinical Nutrition Department, Civic Campus, The Ottawa Hospital, Ottawa, ON K1Y 4E9, Canada"},{"name":"Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON K1Y 4W7, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Constan\u00e7a","family":"Silva","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7368-3127","authenticated-orcid":false,"given":"D. Dan","family":"Ramdath","sequence":"additional","affiliation":[{"name":"College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam H.","family":"Metherel","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1040-6229","authenticated-orcid":false,"given":"Lawrence A.","family":"Leiter","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"Li Ka Shing Knowledge Institute, St. Michael\u2019s Hospital, Toronto, ON M5B 1A6, Canada"},{"name":"Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Division of Endocrinology and Metabolism, Department of Medicine, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard P.","family":"Bazinet","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cyril W. C.","family":"Kendall","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1192-9571","authenticated-orcid":false,"given":"David J. A.","family":"Jenkins","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"Li Ka Shing Knowledge Institute, St. Michael\u2019s Hospital, Toronto, ON M5B 1A6, Canada"},{"name":"Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Division of Endocrinology and Metabolism, Department of Medicine, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Chiavaroli","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"Li Ka Shing Knowledge Institute, St. Michael\u2019s Hospital, Toronto, ON M5B 1A6, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3270-5772","authenticated-orcid":false,"given":"John L.","family":"Sievenpiper","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Toronto 3D Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"},{"name":"Li Ka Shing Knowledge Institute, St. Michael\u2019s Hospital, Toronto, ON M5B 1A6, Canada"},{"name":"Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A8, Canada"},{"name":"Division of Endocrinology and Metabolism, Department of Medicine, St. Michael\u2019s Hospital, Toronto, ON M5B 1W8, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1658","DOI":"10.1161\/CIRCULATIONAHA.107.739714","article-title":"Abdominal Obesity and the Risk of All-Cause, Cardiovascular, and Cancer Mortality","volume":"117","author":"Zhang","year":"2008","journal-title":"Circulation"},{"key":"ref_2","first-page":"e984","article-title":"Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association","volume":"143","author":"Poirier","year":"2021","journal-title":"Circulation"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1781","DOI":"10.1007\/s00125-008-1116-7","article-title":"Pathogenesis of type 2 diabetes: Tracing the reverse route from cure to cause","volume":"51","author":"Taylor","year":"2008","journal-title":"Diabetologia"},{"key":"ref_4","unstructured":"WHO (2015). 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