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
| Registry | NCT02610322 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 208 (Estimated) |
| Sponsor | Chinese University of Hong Kong (Other) |
| Conditions | Metabolic Syndrome |
| Interventions | Whole soy replacement diet, usual diet (Behavioral) |
| Dates | start 2016-06-01, primary completion 2017-12-01 (estimated), completion 2018-12-01 (estimated), first posted 2015-11-20, last updated 2015-11-20 |
Related Papers Related Patents Related Grants Related Experts
All trials for Metabolic Syndrome All trials of Whole soy replacement diet All trials of usual diet
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Whole soy group | Experimental | Behavioral: Whole soy replacement diet | Whole soy replacement diet: to incorporate 4 servings of whole soy foods (equivalent to 25g soy protein) into their daily diet and reduce high saturated fat and cholesterol rich animal foods. |
| Control group | Placebo comparator | Behavioral: usual diet | Usual diet: to receive a conventional lifestyle education on MetS. |
Sex: Female, ages: 45 Years to 70 Years, accepts healthy volunteers
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.