Clinical trial NCT02610322: Whole Soy Replacement Diet on Metabolic Features
Official title: A Randomized Controlled Trial of Whole Soy Diet in Place of Red/Processed Meat and High Fat Dairy Products on Metabolic Features in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 208
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Project title: A randomized controlled trial of whole soy diet in place of red/processed meat and high fat dairy products on metabolic features in postmenopausal women Objectives: Metabolic syndrome (MetS) is an escalating public health problem especially in postmenopausal women. Traditional whole soy foods are rich in unsaturated fats, high quality plant protein and various bioactive phytochemicals that could benefit on MetS. The aim of the study is to examine the effect of whole soy replacement diet on the features of MetS among postmenopausal women.

Hypothesis to be tested: Whole soy diet in place of red or processed meat and high fat dairy products will significantly improve metabolic features.

Design and subjects: This will be a 12-month randomized, single-blind, controlled trial among 208 postmenopausal women with high risk of MetS or early MetS.

Study instruments: After 4 weeks' run-in, participants will be randomly allocated to either of two intervention groups, whole soy replacement group or control group, each for 6 months.

Interventions: Subjects in whole soy group will be required to include 4 servings of whole soy foods (containing 25g soy protein) into their daily diet isocalorically replacing red or processed meat and high fat dairy products. Subjects in the control group will remain an usual diet.

Main outcome measures: The outcome measures will include the indices of metabolic features as well as a 10-year risk for ischemic cardiovascular disease.

Data analysis: The changes and %change of the metabolic features at 6- and 12-month will be compared among the two groups.

Expected results: Whole soy diet substitution of high saturated fat and cholesterol rich animal products will notably decrease the risk of MetS.


Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women aged 45\~70y within 15 years after menopause;
2. Participants who meet 2 or more of the following items:

   * waist circumference WC ≥80 cm;
   * triglyceride concentration ≥1.7 mmol/l;
   * HDL-c \<50 mg/dl (1.29 mmol/l);
   * SBP/DBP ≥130/85 mm Hg;
   * fasting glucose ≥5.6 mmol/l.

Exclusion Criteria:

1. On use of medications known to affect body weight, lipids and glucose within past 3-month;
2. Medical history or presence of severe systemic or endocrine diseases;
3. Present or history of breast, endometrial or ovarian cancer;
4. Abnormal uterine bleeding after menopause;
5. On prescribed or vegetarian diet;
6. Known soy allergy.

Primary outcomes:
measure: Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose).
timeFrame: Will be measured at baseline, 6-month and 12-month after intervention.
Secondary outcomes:
measure: Changes of 10-year risk for ischemic cardiovascular disease (ICVD)
timeFrame: Will be assessed at baseline and 12-month after intervention.
Other outcomes:
Locations:
Study officials:
References:
citation: Liu ZM, Ho S, Hao YT, Chen YM, Woo J, Wong SY, He Q, Xie YJ, Tse LA, Chen B, Su XF, Lao XQ, Wong C, Chan R, Ling WH. Randomised controlled trial of effect of whole soy replacement diet on features of metabolic syndrome in postmenopausal women: study protocol. BMJ Open. 2016 Sep 27;6(9):e012741. doi: 10.1136/bmjopen-2016-012741.