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CompletedNCT00951912Updated Oct 17, 2012Results posted

The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids

An interventional study of Placebo and Daidzein in Type 2 Diabetes Mellitus, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-10-17.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • genistein
  • daidzein
  • impaired glucose regulation
  • glucose metabolism
  • lipids metabolism
  • inflammation
  • women
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 165 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Chinese women aged 30-70 y
  • Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l

Exclusion criteria

Exclusion Criteria:

  • Diabetes renal diseases
  • Confirmed CVD, chronic liver,kidney diseases,Thyroid disease
  • Medications affecting glucose or lipid metabolism
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    10g soy protein isolated powder patch by mouth everyday for 6months

    Dietary Supplement: Placebo

  • Experimental
    Daidzein

    10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months

    Dietary Supplement: Daidzein

  • Experimental
    Genistein

    10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months

    Dietary Supplement: Genistein

Interventions

  • Dietary supplementPlacebo

    10g soy protein isolated per day

  • Dietary supplementDaidzein

    50mg daidzein +10g soy protein isolated per day

  • Dietary supplementGenistein

    50mg genistein +10g soy protein isolated per day

06

What researchers measure

Primary outcomes

  1. Percentage Change in Fasting Plasma Glucose

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline,6 months

  2. Percentage Change in 120-minutes Postload Plasma Glucose

    (6th month value-baseline value)/baseline\*100%

    Time frame: Baseline, 6 months

  3. Percentage Change in HbA1C

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline, 6 months

  4. 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%

    Time frame: Baseline, 6 months

  5. Percentage Change in Fasting Plasma Insulin

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline, 6 months

  6. 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%

    Time frame: Baseline, 6 months

  7. 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%

    Time frame: Baseline, 6 months

  8. Percentage Change in Total Cholesterol

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline, 6 months

  9. Percentage Change in Triglyceride

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline, 6 months

  10. Percentage Change in High Density Lipoprotein Cholesterol

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline, 6 months

  11. Percentage Change in Low Density Lipoprotein Cholesterol

    (6th month value-baseline value)/baseline value\*100%

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Total Urinary Isoflavones

    Time frame: 3 months

  2. Urinary Daidzein

    Urinary daidzein excretion

    Time frame: 3 months

  3. Urinary Genistein

    Urinary genistein excretion

    Time frame: 3 months

  4. Total Energy Intake at Follow-up

    The energy intake was evaluated by 3 days dietary records.

    Time frame: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.

07

Results

Posted Oct 16, 2012
Limitations and caveats
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.

Participant flow

the recruitment period last about half a year,and the types of location are clinic of endocrinology and nutritional clinic

Participant flow — Overall Study
MilestonePlaceboDaidzeinGenistein
Started545556
Completed475054
Not completed752
Withdrew: Lack of efficacy100
Withdrew: Adverse event011
Withdrew: Lost to follow-up220
Withdrew: Physician decision101
Withdrew: Withdrawal by subject110
Withdrew: Other:depression100
Withdrew: Other: colon cancer100
Withdrew: Other: stroke010

Outcome measures

PrimaryPercentage Change in Fasting Plasma Glucose

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline,6 months
Reported as:
Mean · percentage of change
Percentage Change in Fasting Plasma Glucose
percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in Fasting Plasma Glucose-1.80 ± 13.5-1.00 ± 12.61-4.89 ± 11.79
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -0.7981 · 95% CI -6.6569 to 5.0607
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 3.0842 · 95% CI -2.7486 to 8.9171
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 3.8823 · 95% CI -1.9234 to 9.6881
PrimaryPercentage Change in 120-minutes Postload Plasma Glucose

(6th month value-baseline value)/baseline\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · percentage of change
Percentage Change in 120-minutes Postload Plasma Glucose
percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in 120-minutes Postload Plasma Glucose-4.90 ± 20.67-3.13 ± 20.60-5.59 ± 24.23
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -1.7696 · 95% CI -11.9308 to 8.3916
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 0.6929 · 95% CI -9.4232 to 10.8091
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 2.4626 · 95% CI -7.6067 to 12.5318
PrimaryPercentage Change in HbA1C

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · percentage of change
Percentage Change in HbA1C
percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in HbA1C-1.38 ± 7.17-1.37 ± 5.99-1.30 ± 9.29
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -0.01174 · 95% CI -3.5428 to 3.5194
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -2.68659 · 95% CI -6.2020 to 0.8288
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -2.67485 · 95% CI -6.174 to 0.8243
PrimaryPercentage 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%

Time frame:
Baseline, 6 months
Reported as:
Mean · percentage of change
Percentage Change in AUC of Glucose
percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in AUC of Glucose-6.23 ± 14.06-3.27 ± 16.98-5.24 ± 17.96
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -2.9661 · 95% CI -10.5857 to 4.6535
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Odds ratio, log: -0.9972 · 95% CI -8.5830 to 6.5886
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Median difference (net): 1.9689 · 95% CI -5.5817 to 9.5195
PrimaryPercentage Change in Fasting Plasma Insulin

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · percentage of change
Percentage Change in Fasting Plasma Insulin
percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in Fasting Plasma Insulin25.27 ± 114.2321.41 ± 91.236.06 ± 78.26
Statistical analysis
  • Placebo Group vs Daidzein Group vs Geinstein Group · Kruskal-Wallis · p = <0.05 · Mean rank: 1.442
PrimaryPercentage 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%

Time frame:
Baseline, 6 months
Reported as:
Mean · Percentage of change
Percentage Change in HOMA-IR
Percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in HOMA-IR22.83 ± 107.4121.60 ± 98.88-0.22 ± 64.03
Statistical analysis
  • Placebo Group vs Daidzein Group vs Geinstein Group · Kruskal-Wallis · p = <0.05 · Mean ranks: 1.895
PrimaryPercentage 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%

Time frame:
Baseline, 6 months
Reported as:
Mean · Percentage of change
Percentage Change in QUICKI
Percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in QUICKI2.32 ± 19.470.18 ± 15.606.29 ± 17.77
Statistical analysis
  • Placebo Group vs Daidzein Group vs Geinstein Group · Kruskal-Wallis · p = <0.05 · Mean ranks: 2.169
PrimaryPercentage Change in Total Cholesterol

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · Percentage of change
Percentage Change in Total Cholesterol
Percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in Total Cholesterol2.85 ± 40.06-0.59 ± 11.90-0.64 ± 15.83
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): 3.4370 · 95% CI -8.444 to 15.318
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 3.4809 · 95% CI -8.3475 to 15.3092
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 0.0439 · 95% CI -11.7296 to 11.8174
PrimaryPercentage Change in Triglyceride

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · Percentage of change
Percentage Change in Triglyceride
Percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in Triglyceride5.93 ± 45.503.43 ± 38.90-1.56 ± 39.15
Statistical analysis
  • Placebo Group vs Daidzein Group vs Geinstein Group · Kruskal-Wallis · p = <0.05 · Mean ranks: 1.031
PrimaryPercentage Change in High Density Lipoprotein Cholesterol

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · Percentage of change
Percentage Change in High Density Lipoprotein Cholesterol
Percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in High Density Lipoprotein Cholesterol3.18 ± 20.401.36 ± 15.212.15 ± 14.54
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): 1.8185 · 95% CI -6.0057 to 9.6426
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 1.0276 · 95% CI -6.7619 to 8.8170
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -0.7909 · 95% CI -8.5442 to 6.9624
PrimaryPercentage Change in Low Density Lipoprotein Cholesterol

(6th month value-baseline value)/baseline value\*100%

Time frame:
Baseline, 6 months
Reported as:
Mean · Percentage of change
Percentage Change in Low Density Lipoprotein Cholesterol
Percentage of changePlacebo GroupDaidzein GroupGeinstein Group
Percentage Change in Low Density Lipoprotein Cholesterol1.08 ± 24.46-0.93 ± 21.211.86 ± 19.39
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): 2.0122 · 95% CI -8.0721 to 12.0964
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -0.7716 · 95% CI -10.8111 to 9.2679
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -2.7837 · 95% CI -12.7767 to 7.2092
SecondaryTotal Urinary Isoflavones
Time frame:
3 months
Reported as:
Geometric mean · ug/ml
Total Urinary Isoflavones
ug/mlPlacebo GroupDaidzein GroupGeinstein Group
Total Urinary Isoflavones8.538 ± 10.15325.818 ± 31.78015.467 ± 22.022
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -0.4437 · 95% CI -0.6416 to -0.2458
  • Placebo Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -0.1986 · 95% CI -0.3956 to -0.0016
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 0.2451 · 95% CI 0.0544 to 0.4358
SecondaryUrinary Daidzein

Urinary daidzein excretion

Time frame:
3 months
Reported as:
Geometric mean · ug/ml
Urinary Daidzein
ug/mlPlacebo GroupDaidzein GroupGeinstein Group
Urinary Daidzein3.34 ± 4.8111.80 ± 11.143.73 ± 8.83
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -0.6353 · 95% CI -0.8617 to -0.4089
  • Placebo Group vs Geinstein Group · ANOVA · p = 0.05 · Mean difference (net): 0.0282 · 95% CI -0.2003 to 0.2568
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): 0.6635 · 95% CI 0.4419 to 0.8851
SecondaryUrinary Genistein

Urinary genistein excretion

Time frame:
3 months
Reported as:
Geometric mean · ug/ml
Urinary Genistein
ug/mlPlacebo GroupDaidzein GroupGeinstein Group
Urinary Genistein1.32 ± 1.721.89 ± 2.596.54 ± 8.97
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): -0.1557 · 95% CI -0.3911 to 0.0796
  • Placebo Group vs Geinstein Group · ANOVA · p = 0.05 · Mean difference (net): -0.6060 · 95% CI -0.8414 to -0.3707
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -0.4503 · 95% CI -0.6804 to -0.2202
SecondaryTotal Energy Intake at Follow-up

The energy intake was evaluated by 3 days dietary records.

Time frame:
an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.
Reported as:
Mean · kcal
Total Energy Intake at Follow-up
kcalPlacebo GroupDaidzein GroupGeinstein Group
Total Energy Intake at Follow-up1575 ± 5751473 ± 2941579 ± 367
Statistical analysis
  • Placebo Group vs Daidzein Group · ANOVA · p = <0.05 · Mean difference (net): 102.4 · 95% CI -99.3 to 304.1
  • Placebo Group vs Geinstein Group · ANOVA · p = 0.05 · Mean difference (net): -3.8 · 95% CI -203.7 to 196.1
  • Daidzein Group vs Geinstein Group · ANOVA · p = <0.05 · Mean difference (net): -106.2 · 95% CI -305.1 to 92.8

Adverse events

Collected over We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/54 (0%)4/54 (7.4%)
Daidzein—0/55 (0%)4/55 (7.3%)
Genistein—0/56 (0%)2/56 (3.6%)
Most frequent other events
Most frequent other events
EventPlaceboDaidzeinGenistein
thirstyGastrointestinal disorders2/542/551/56
vignal bleedingReproductive system and breast disorders1/541/550/56
hyperplasia of mammary glandsEndocrine disorders1/540/550/56
flatulenceGastrointestinal disorders0/541/550/56
proteinuriaRenal and urinary disorders0/540/551/56

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboDaidzeinGenisteinTotal
<=18 years0000
Between 18 and 65 years434342128
>=65 years11121437
Age Continuous
Age Continuous(years)PlaceboDaidzeinGenisteinTotal
Mean56.31 ± 11.0756.36 ± 9.9057.02 ± 9.6856.57 ± 10.17
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDaidzeinGenisteinTotal
Female545556165
Male0000
Region of Enrollment
Region of Enrollment(participants)PlaceboDaidzeinGenisteinTotal
China545556165
08

Study locations

1 site
  • The First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00951912
Lead sponsor
Sun Yat-sen University
Collaborators
Chinese Nutrition Society, Danone Institute International, Department of Health of Guangdong Province
Responsible party
yanbinye (Associate professor, Sun Yat-sen University) — Principal investigator
First posted
Aug 4, 2009
Start date
Aug 2009
Primary completion
Jun 2011
Completion
Sep 2011
Results posted
Oct 16, 2012
Last update
Oct 17, 2012

Study contacts

Yan-bin Ye, MD
principal investigator · Sun Yat-sen University
Yu-ming Chen, PhD
study director · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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