Metabolic SyndromeNCT02610322
Whole Soy Replacement Diet on Metabolic Features
A study testing Whole soy replacement diet and usual diet in people with Metabolic Syndrome, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Whole soy replacement diet and usual diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 45~70y within 15 years after menopause;
- 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.
Who cannot join
- On use of medications known to affect body weight, lipids and glucose within past 3-month;
- Medical history or presence of severe systemic or endocrine diseases;
- Present or history of breast, endometrial or ovarian cancer;
- Abnormal uterine bleeding after menopause;
- On prescribed or vegetarian diet;
- Known soy allergy.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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.
- Conditions
- Metabolic Syndrome
- Being tested
- Whole soy replacement diet, usual diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole soy replacement dietBehavioural
Participants who are allocated to Whole soy group will receive a 30~40 min counseling session by an experienced nutritionist on: 1) conventional lifestyle education on metabolic syndrome (MetS); 2) The benefits of whole soy diet; 2) Practical techniques to incorporate of 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 based on their prior 7-day dietary record during run-in; (3) Participants will also receive a pamphlet and an 30 min DVD which will provide practical cooking recipes with both illustration and demonstration on how to prepare whole soy foods/diet in an easy and fun way to replace fatty animal meat and dairy products
usual dietBehavioural
Participants who are assigned to the usual diet group (control group) will receive a 5~10 min conventional lifestyle education on MetS by a research staff in which the general recommendation for macronutrient composition of the control diet will be 50-60% of energy as carbohydrate, 15-20% of energy as protein, and <30% of energy as total fat.
| Study group | Role | What they receive |
|---|---|---|
| Whole soy group | Experimental | 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. Receives: Behavioral: Whole soy replacement diet |
| Control group | Placebo comparator | Usual diet: to receive a conventional lifestyle education on MetS. Receives: Behavioral: usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose).
Measured: Will be measured at baseline, 6-month and 12-month after intervention.
Secondary outcomes (1)
Changes of 10-year risk for ischemic cardiovascular disease (ICVD)
Measured: Will be assessed at baseline and 12-month after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhaomin, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610322
- Sponsor's protocol ID
- CRE-2013.121
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27678545
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02610322
- Acronym / sponsor ID
- CRE-2013.121
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole soy group | Experimental | Behavioral: Whole soy replacement dietWhole 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 dietUsual diet: to receive a conventional lifestyle education on MetS. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal women aged 45~70y within 15 years after menopause;
- Participants who meet 2 or more of the following items:
Key exclusion criteria (6 listed)
- On use of medications known to affect body weight, lipids and glucose within past 3-month;
- Medical history or presence of severe systemic or endocrine diseases;
- Present or history of breast, endometrial or ovarian cancer;
- Abnormal uterine bleeding after menopause;
- On prescribed or vegetarian diet;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole soy replacement dietParticipants who are allocated to Whole soy group will receive a 30~40 min counseling session by an experienced nutritionist on: 1) conventional lifestyle education on metabolic syndrome (MetS); 2) The benefits of whole soy diet; 2) Practical techniques to incorporate of 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 based on their prior 7-day dietary record during run-in; (3) Participants will also receive a pamphlet and an 30 min DVD which will provide practical cooking recipes with both illustration and demonstration on how to prepare whole soy foods/diet in an easy and fun way to replace fatty animal meat and dairy products | Behavioural | Whole soy group |
| usual dietParticipants who are assigned to the usual diet group (control group) will receive a 5~10 min conventional lifestyle education on MetS by a research staff in which the general recommendation for macronutrient composition of the control diet will be 50-60% of energy as carbohydrate, 15-20% of energy as protein, and <30% of energy as total fat. | Behavioural | Control group |
Primary outcome
Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose).
Time frame: Will be measured at baseline, 6-month and 12-month after intervention.
1 secondary outcome
Changes of 10-year risk for ischemic cardiovascular disease (ICVD)
Time frame: Will be assessed at baseline and 12-month after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 27678545Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Whole soy replacement diet and usual diet in people with Metabolic Syndrome, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhao-min Liu, PhD (2252-8790, liuzhaomin@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of metabolic components of MetS (body weight, waist circumference, blood pressure, serum lipids and fasting glucose). (time frame: Will be measured at baseline, 6-month and 12-month after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015; AzTrials last refreshed its copy on 30 Oct 2026.