DiabetesNCT00856882
The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors
A study testing soy protein, isoflavones and milk protein in people with Diabetes and Cardiovascular Risk, run by Chinese University of Hong Kong.
Trial summary
The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes. Read more about this study
- Who is it for?
- Ages 46 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Cardiovascular Risk
- What is being tested?
- soy protein, isoflavones and milk protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2007to Apr 2008
- 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 46 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes
Who cannot join
- Women with breast, ovary or other cancers in recent 5-year
- Severe renal or liver dysfunction
- Women with androgen excess
- Smokers
- Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.
About this study
Official title: The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women
The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.
- Conditions
- Diabetes, Cardiovascular Risk
- Being tested
- soy protein, isoflavones, milk protein
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy proteinDietary supplement
isoflavonesDietary supplement
milk proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| soy protein and isoflavones | Experimental | Not described Receives: Dietary Supplement: soy protein; Dietary Supplement: isoflavones |
| milk protein and isoflavones | Experimental | Not described Receives: Dietary Supplement: isoflavones; Dietary Supplement: milk protein |
| milk protein only | Placebo comparator | Not described Receives: Dietary Supplement: milk protein |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startOct 2007
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856882
- Sponsor's protocol ID
- CUHK4450/06M
- Status last verified
- Mar 2009
- First submitted
- 5 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu ZM, Ho CS, Chen YM, Woo J. Can soy intake affect serum uric acid level? Pooled analysis from two 6-month randomized controlled trials among Chinese postmenopausal women with prediabetes or prehypertension. Eur J Nutr. 2015 Feb;54(1):51-8. doi: 10.1007/s00394-014-0684-1.
PubMed 24659208Liu ZM, Ho SC, Chen YM, Ho YP. A mild favorable effect of soy protein with isoflavones on body composition--a 6-month double-blind randomized placebo-controlled trial among Chinese postmenopausal women. Int J Obes (Lond). 2010 Feb;34(2):309-18. doi: 10.1038/ijo.2009.236. Epub 2009 Nov 17.
PubMed 19918248
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00856882
- Acronym / sponsor ID
- CUHK4450/06M
- Conditions
- Diabetes, Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 6 Mar 2009 (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.
The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| soy protein and isoflavones | Experimental | Dietary Supplement: soy protein, Dietary Supplement: isoflavones |
| milk protein and isoflavones | Experimental | Dietary Supplement: isoflavones, Dietary Supplement: milk protein |
| milk protein only | Placebo comparator | Dietary Supplement: milk protein |
Who may qualify
- Ages
- 46 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes
Key exclusion criteria (5 listed)
- Women with breast, ovary or other cancers in recent 5-year
- Severe renal or liver dysfunction
- Women with androgen excess
- Smokers
- Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.
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 |
|---|---|---|
| soy protein | Dietary supplement | soy protein and isoflavones |
| isoflavones | Dietary supplement | milk protein and isoflavones, soy protein and isoflavones |
| milk protein | Dietary supplement | milk protein and isoflavones, milk protein only |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
- Derived from this study: PubMed 24659208Liu ZM, Ho CS, Chen YM, Woo J. Can soy intake affect serum uric acid level? Pooled analysis from two 6-month randomized controlled trials among Chinese postmenopausal women with prediabetes or prehypertension. Eur J Nutr. 2015 Feb;54(1):51-8. doi: 10.1007/s00394-014-0684-1.
- Derived from this study: PubMed 19918248Liu ZM, Ho SC, Chen YM, Ho YP. A mild favorable effect of soy protein with isoflavones on body composition--a 6-month double-blind randomized placebo-controlled trial among Chinese postmenopausal women. Int J Obes (Lond). 2010 Feb;34(2):309-18. doi: 10.1038/ijo.2009.236. Epub 2009 Nov 17.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing soy protein, isoflavones and milk protein in people with Diabetes and Cardiovascular Risk, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 6 Mar 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00856882, which also lists 2 linked publications.
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 6 Mar 2009.