- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951912
The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- The First Affiliated Hospital, Sun Yat-sen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chinese women aged 30-70 y
- Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l
Exclusion Criteria:
- Diabetes renal diseases
- Confirmed CVD, chronic liver,kidney diseases,Thyroid disease
- Medications affecting glucose or lipid metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
10g soy protein isolated powder patch by mouth everyday for 6months
|
10g soy protein isolated per day
|
EXPERIMENTAL: Daidzein
10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months
|
50mg daidzein +10g soy protein isolated per day
|
EXPERIMENTAL: Genistein
10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months
|
50mg genistein +10g soy protein isolated per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change in Fasting Plasma Glucose
Time Frame: Baseline,6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline,6 months
|
Percentage Change in 120-minutes Postload Plasma Glucose
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline*100%
|
Baseline, 6 months
|
Percentage Change in HbA1C
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline, 6 months
|
Percentage Change in AUC of Glucose
Time Frame: Baseline, 6 months
|
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
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline, 6 months
|
Percentage Change in HOMA-IR
Time Frame: Baseline, 6 months
|
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
Time Frame: Baseline, 6 months
|
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
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline, 6 months
|
Percentage Change in Triglyceride
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline, 6 months
|
Percentage Change in High Density Lipoprotein Cholesterol
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline, 6 months
|
Percentage Change in Low Density Lipoprotein Cholesterol
Time Frame: Baseline, 6 months
|
(6th month value-baseline value)/baseline value*100%
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Urinary Isoflavones
Time Frame: 3 months
|
3 months
|
|
Urinary Daidzein
Time Frame: 3 months
|
Urinary daidzein excretion
|
3 months
|
Urinary Genistein
Time Frame: 3 months
|
Urinary genistein excretion
|
3 months
|
Total Energy Intake at Follow-up
Time Frame: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yan-bin Ye, MD, Sun Yat-sen University
- Study Director: Yu-ming Chen, PhD, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Estrogens, Non-Steroidal
- Estrogens
- Protein Kinase Inhibitors
- Anticarcinogenic Agents
- Phytoestrogens
- Genistein
- Daidzein
Other Study ID Numbers
- yanbinye
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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