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| Name | Class |
|---|---|
| Chinese Nutrition Society | UNKNOWN |
| Danone Institute International | OTHER |
| Department of Health of Guangdong Province | UNKNOWN |
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Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and daidzein) on glucose metabolism. This double-blinded, randomized, placebo-controlled trial will examine the effects of purified genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be recruited and randomly allocated into the following three arms: Placebo (10g isolated soy protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be compared among the three groups.
Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6 to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed diabetes not requiring medication treatment according to a doctor's suggestion or participants did not willing to take medication themselves, and managed their diabetes just with a stable diet and exercise. Women were excluded if they had a history of coronary heart disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction agents; were occurrence of diabetic complications; use of hormone replacement therapy; allergy to soy;were long-term antibiotics users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 10g soy protein isolated powder patch by mouth everyday for 6months |
|
| Daidzein | Experimental | 10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months |
|
| Genistein | Experimental | 10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 10g soy protein isolated per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Fasting Plasma Glucose | (6th month value-baseline value)/baseline value*100% | Baseline,6 months |
| Percentage Change in 120-minutes Postload Plasma Glucose | (6th month value-baseline value)/baseline*100% | Baseline, 6 months |
| Percentage Change in HbA1C | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in AUC of Glucose | values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in Fasting Plasma Insulin | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in HOMA-IR | HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in QUICKI | QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100% |
| Measure | Description | Time Frame |
|---|---|---|
| Total Urinary Isoflavones | 3 months | |
| Urinary Daidzein | Urinary daidzein excretion | 3 months |
| Urinary Genistein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan-bin Ye, MD | Sun Yat-sen University | Principal Investigator |
| Yu-ming Chen, PhD | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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the recruitment period last about half a year,and the types of location are clinic of endocrinology and nutritional clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | the placebo group were given 10g soy protein isolated without isoflavones |
| FG001 | Daidzein | Daidzein group were given 10g soy protein isolated and 50mg purify daidzein |
| FG002 | Genistein | Genistein group were given 10g soy protein isolated and 50mg purify genistein |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | the placebo group were given 10g soy protein isolated without isoflavones |
| BG001 | Daidzein | Daidzein group were given 10g soy protein isolated and 50mg purify daidzein |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Fasting Plasma Glucose | (6th month value-baseline value)/baseline value*100% | the number of participants for analysis was determined by intention to treat | Posted | Mean | Standard Deviation | percentage of change | Baseline,6 months |
|
We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | the placebo group were given 10g soy protein isolated without isoflavones |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vignal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
A relative long time of recruitment leading to a little different in dietary intakes among subjects;The menstrual period will leading to different estradiol;The different severity of the diabetes leading to the different dropout percentage.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yan-bin Ye | the First Affiliated Hospital of Sun Yat-sen University | 8620-87755766 | 8179 | yanbinye72@163.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C004742 | daidzein |
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Daidzein |
| Dietary Supplement |
50mg daidzein +10g soy protein isolated per day |
|
| Genistein | Dietary Supplement | 50mg genistein +10g soy protein isolated per day |
|
| Baseline, 6 months |
| Percentage Change in Total Cholesterol | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in Triglyceride | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in High Density Lipoprotein Cholesterol | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
| Percentage Change in Low Density Lipoprotein Cholesterol | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months |
Urinary genistein excretion |
| 3 months |
| Total Energy Intake at Follow-up | The energy intake was evaluated by 3 days dietary records. | an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other:Depression |
|
| Other: Colon cancer |
|
| Other: Stroke |
|
| BG002 | Genistein | Genistein group were given 10g soy protein isolated and 50mg purify genistein |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All participants were received 10g soy protein isolated plus 50mg purify genistein daily |
|
|
|
| Primary | Percentage Change in 120-minutes Postload Plasma Glucose | (6th month value-baseline value)/baseline*100% | All participants were determinted by intention to treat | Posted | Mean | Standard Deviation | percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in HbA1C | (6th month value-baseline value)/baseline value*100% | The number of participants analyzed was determinted by intention to treat. | Posted | Mean | Standard Deviation | percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in AUC of Glucose | values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100% | The number of patticipants was determinted by intention to treat | Posted | Mean | Standard Deviation | percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in Fasting Plasma Insulin | (6th month value-baseline value)/baseline value*100% | The number of participants was determinted by intention to treat | Posted | Mean | Standard Deviation | percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in HOMA-IR | HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100% | The number of participants for analysis was determinted by intention to treat | Posted | Mean | Standard Deviation | Percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in QUICKI | QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100% | The number of participants for analysis was determinted by intention to treat | Posted | Mean | Standard Deviation | Percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in Total Cholesterol | (6th month value-baseline value)/baseline value*100% | The number of participants for analysis was determinted by intention to treat | Posted | Mean | Standard Deviation | Percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in Triglyceride | (6th month value-baseline value)/baseline value*100% | The number of participants for analysis was determinted by intention to treat | Posted | Mean | Standard Deviation | Percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in High Density Lipoprotein Cholesterol | (6th month value-baseline value)/baseline value*100% | Posted | Mean | Standard Deviation | Percentage of change | Baseline, 6 months |
|
|
|
|
| Primary | Percentage Change in Low Density Lipoprotein Cholesterol | (6th month value-baseline value)/baseline value*100% | The number of participants for analysis was determinted by intention to treat | Posted | Mean | Standard Deviation | Percentage of change | Baseline, 6 months |
|
|
|
|
| Secondary | Total Urinary Isoflavones | The number of participants for analysis was determinted by the participants who provided the urine samples at the 3-month test. | Posted | Geometric Mean | Standard Deviation | ug/ml | 3 months |
|
|
|
|
| Secondary | Urinary Daidzein | Urinary daidzein excretion | The number of participants for analysis was determinted by the number of participants who provided urine samples at the 3-month test | Posted | Geometric Mean | Standard Deviation | ug/ml | 3 months |
|
|
|
|
| Secondary | Urinary Genistein | Urinary genistein excretion | The number of participants for analysis was determinted by the number of participants who supplied the urine samples at the 3-month test | Posted | Geometric Mean | Standard Deviation | ug/ml | 3 months |
|
|
|
|
| Secondary | Total Energy Intake at Follow-up | The energy intake was evaluated by 3 days dietary records. | The number of participants for analysis was determinted by intention to treat | Posted | Mean | Standard Deviation | kcal | an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week. |
|
|
|
|
| 0 |
| 54 |
| 4 |
| 54 |
| EG001 | Daidzein | Daidzein group were given 10g soy protein isolated and 50mg purify daidzein | 0 | 55 | 4 | 55 |
| EG002 | Genistein | Genistein group were given 10g soy protein isolated and 50mg purify genistein | 0 | 56 | 2 | 56 |
| hyperplasia of mammary glands | Endocrine disorders | Non-systematic Assessment |
|
| proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| thirsty | Gastrointestinal disorders | Non-systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
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| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Mean Difference (Net) |
| 0.6929 |
| Standard Error of the Mean |
| 4.1818 |
| 2-Sided |
| 95 |
| -9.4232 |
| 10.8091 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | 2.4626 | Standard Error of the Mean | 4.1624 | 2-Sided | 95 | -7.6067 | 12.5318 | No | Superiority or Other |
| Mean Difference (Net) |
| -2.68659 |
| Standard Error of the Mean |
| 1.45320 |
| 2-Sided |
| 95 |
| -6.2020 |
| 0.8288 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | -2.67485 | Standard Error of the Mean | 1.44646 | 2-Sided | 95 | -6.174 | 0.8243 | No | Superiority or Other |
| Odds Ratio, log |
| -0.9972 |
| Standard Error of the Mean |
| 3.13581 |
| 2-Sided |
| 95 |
| -8.5830 |
| 6.5886 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Median Difference (Net) | 1.9689 | Standard Error of the Mean | 3.12126 | 2-Sided | 95 | -5.5817 | 9.5195 | No | Superiority or Other |
| Mean Difference (Net) |
| 3.4809 |
| Standard Error of the Mean |
| 4.8896 |
| 2-Sided |
| 95 |
| -8.3475 |
| 15.3092 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | 0.0439 | Standard Error of the Mean | 4.8669 | 2-Sided | 95 | -11.7296 | 11.8174 | No | Superiority or Other |
| Mean Difference (Net) |
| 1.0276 |
| Standard Error of the Mean |
| 3.2199 |
| 2-Sided |
| 95 |
| -6.7619 |
| 8.8170 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | -0.7909 | Standard Error of the Mean | 3.2050 | 2-Sided | 95 | -8.5442 | 6.9624 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.7716 |
| Standard Error of the Mean |
| 4.1501 |
| 2-Sided |
| 95 |
| -10.8111 |
| 9.2679 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | -2.7837 | Standard Error of the Mean | 4.1309 | 2-Sided | 95 | -12.7767 | 7.2092 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.1986 |
| Standard Error of the Mean |
| 0.09986 |
| 2-Sided |
| 95 |
| -0.3956 |
| -0.0016 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | 0.2451 | Standard Error of the Mean | 0.09648 | 2-Sided | 95 | 0.0544 | 0.4358 | No | Superiority or Other |
| Mean Difference (Net) |
| 0.0282 |
| Standard Error of the Mean |
| 0.1156 |
| 2-Sided |
| 95 |
| -0.2003 |
| 0.2568 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | 0.6635 | Standard Error of the Mean | 0.1121 | 2-Sided | 95 | 0.4419 | 0.8851 | No | Superiority or Other |
| Mean Difference (Net) |
| -0.6060 |
| Standard Error of the Mean |
| 0.1190 |
| 2-Sided |
| 95 |
| -0.8414 |
| -0.3707 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | -0.4503 | Standard Error of the Mean | 0.1163 | 2-Sided | 95 | -0.6804 | -0.2202 | No | Superiority or Other |
| Mean Difference (Net) |
| -3.8 |
| Standard Error of the Mean |
| 82.6 |
| 2-Sided |
| 95 |
| -203.7 |
| 196.1 |
| No |
| Superiority or Other |
| ANOVA | <0.05 | Mean Difference (Net) | -106.2 | Standard Error of the Mean | 82.2 | 2-Sided | 95 | -305.1 | 92.8 | No | Superiority or Other |