Liu Zhao-Min, Ho Suzanne, Hao Yuan-Tao, Chen Yu-Ming, Woo Jean, Wong Samuel Yeung-Shan, He Qiqiang, Xie Yao Jie, Tse Lap Ah, Chen Bailing, Su Xue-Fen, Lao Xiang-Qian, Wong Carmen, Chan Ruth, Ling Wen-Hua
School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
BMJ Open. 2016 Sep 27;6(9):e012741. doi: 10.1136/bmjopen-2016-012741.
Metabolic syndrome (MetS) is a public health problem in postmenopausal women. Whole soy foods are rich in unsaturated fats, high quality plant protein and various bioactive phytochemicals that may have a beneficial role in the management of MetS. The aim of the study is to examine the effect of whole soy replacement diet on the features of MetS among postmenopausal women.
This will be a 12-month, randomised, single-blind, parallel controlled trial among 208 postmenopausal women at risk of MetS or with early MetS. After 4 weeks' run-in, subjects will be randomly allocated to one of two intervention groups, whole soy replacement group or control group, each for 12 months. Subjects in the whole soy group will be required to include four servings of whole soy foods (containing 25 g soy protein) into their daily diet iso-calorically, replacing red or processed meat and high fat dairy products. Subjects in the control group will remain on a usual diet. The outcome measures will include metabolic parameters as well as a 10-year risk for ischaemic cardiovascular disease. We hypothesise that the whole soy substitution diet will notably improve features of MetS in postmenopausal women at risk of MetS or with early MetS. The study will have both theoretical and practical significance. If proven effective, the application of the whole soy replacement diet model will be a safe, practical and economical strategy for MetS prevention and treatment.
Ethics approval has been obtained from the Ethics Committee of the Chinese University of Hong Kong. The results will be disseminated via conference presentations and papers in academic peer reviewed journals. Data files will be deposited in an accessible repository.
NCT02610322.
代谢综合征（MetS）是绝经后女性面临的一个公共卫生问题。全豆食品富含不饱和脂肪、优质植物蛋白和多种生物活性植物化学物质，可能对代谢综合征的管理具有有益作用。本研究的目的是探讨全豆替代饮食对绝经后女性代谢综合征特征的影响。
这将是一项为期12个月的随机、单盲、平行对照试验，研究对象为208名有代谢综合征风险或患有早期代谢综合征的绝经后女性。经过4周的导入期后，受试者将被随机分配到两个干预组之一，即全豆替代组或对照组，每组为期12个月。全豆组的受试者需要在其日常饮食中等热量地纳入四份全豆食品（含25克大豆蛋白），以替代红肉或加工肉类以及高脂肪乳制品。对照组的受试者将保持常规饮食。结局指标将包括代谢参数以及缺血性心血管疾病的10年风险。我们假设全豆替代饮食将显著改善有代谢综合征风险或患有早期代谢综合征的绝经后女性的代谢综合征特征。本研究将具有理论和实际意义。如果被证明有效，全豆替代饮食模式的应用将是一种安全、实用且经济的代谢综合征防治策略。
已获得香港中文大学伦理委员会的伦理批准。研究结果将通过会议报告和在学术同行评审期刊上发表论文的方式进行传播。数据文件将存放在可访问的存储库中。
NCT02610322。
