Role of Soy for Metabolic Health: The Soy Treatment Evaluation for Metabolic Health (STEM) Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Liver fat
研究概览
简要总结
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.
详细描述
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 hand, it is under threat to have its health claim for CHD risk reduction revoked [10] and is often overshadowed by dairy in public health interventions for metabolic health. Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes [10-22]. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred replacement strategy for SSBs [23-27]. 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 [28,29] and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and BP in randomized trials [30]. Whether these benefits hold for soy milk alternatives, which have shown distinct advantages over cow's milk for intermediate metabolic outcomes [7,31-33], is unclear. There is an urgent need for studies to clarify the metabolic benefits of soy milk as an alternative to cow's milk.
Objective:
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.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of the participants and investigators will not be possible due to packaging, taste and look of the interventions. However, outcome assessors (laboratory, microbiome analysis) and the statistician will be blinded to the identity of the treatments.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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))
排除标准
- •Age <18 or >75 years.
- •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**
结局指标
主要结局
Liver fat
时间窗: End value at week 24
intra-hepatocellular lipid (IHCL) by 1H-MRS measured at weeks 0 and 24
次要结局
- Whole body insulin sensitivity(End value at week 24)
- Beta-cell function(End value at week 24)
- Glucose tolerance - plasma glucose AUC(End value at week 24)
- Glucose tolerance - 2-hour plasma glucose (2h-PG)(End value at week 24)
研究者
John Sievenpiper
Associate Professor
University of Toronto