NCT00951912

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 16, 2012

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

August 3, 2009

Results QC Date

June 26, 2012

Last Update Submit

October 16, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

genisteindaidzeinimpaired glucose regulationglucose metabolismlipids metabolisminflammationwomen

Outcome Measures

Primary Outcomes (11)

  • 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%

    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

Secondary Outcomes (4)

  • Total Urinary Isoflavones

    3 months

  • Urinary Daidzein

    3 months

  • Urinary Genistein

    3 months

  • Total Energy Intake at Follow-up

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Daidzein

EXPERIMENTAL

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

Dietary Supplement: Daidzein

Genistein

EXPERIMENTAL

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

Dietary Supplement: Genistein

Interventions

PlaceboDIETARY_SUPPLEMENT

10g soy protein isolated per day

Placebo
DaidzeinDIETARY_SUPPLEMENT

50mg daidzein +10g soy protein isolated per day

Daidzein
GenisteinDIETARY_SUPPLEMENT

50mg genistein +10g soy protein isolated per day

Genistein

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Inflammation

Interventions

daidzeinGenistein

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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.

Results Point of Contact

Title
Dr. Yan-bin Ye
Organization
the First Affiliated Hospital of Sun Yat-sen University
yanbinye72@163.com
8620-87755766

Study Officials

  • Yan-bin Ye, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yu-ming Chen, PhD

    Sun Yat-sen University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

October 17, 2012

Results First Posted

October 16, 2012

Record last verified: 2012-10

Locations

CN(1)