Randomised controlled trial of effect of whole soy replacement diet on features of metabolic syndrome in postmenopausal women: study protocol.
BACKGROUND
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.


METHODS
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.


BACKGROUND
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.


BACKGROUND
NCT02610322.
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.
Zhao-Min
ZM
Liu
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Suzanne
S
Ho
School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China.
Yuan-Tao
YT
Hao
School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China.
Yu-Ming
YM
Chen
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Jean
J
Woo
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Samuel Yeung-Shan
SY
Wong
School of Public Health, Wuhan University, Wuhan, People's Republic of China.
Qiqiang
Q
He
School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong.
Yao Jie
http://orcid.org/0000-0001-9289-4985
YJ
Xie
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Lap Ah
LA
Tse
Department of Spine Surgery, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, People's Republic of China.
Bailing
B
Chen
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Xue-Fen
XF
Su
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Xiang-Qian
XQ
Lao
Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong.
Carmen
C
Wong
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Ruth
R
Chan
School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China.
Wen-Hua
WH
Ling
metabolic syndromes; randomized controlled trial; replacement diet; whole soy
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