Trial Outcomes & Findings for The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids (NCT NCT00951912)

NCT ID: NCT00951912

Last Updated: 2012-10-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 165 participants
• Primary outcome timeframe: Baseline,6 months
• Results posted on: 2012-10-17

Participant Flow

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

Participant milestones

Measure	Placebo the placebo group were given 10g soy protein isolated without isoflavones	Daidzein Daidzein group were given 10g soy protein isolated and 50mg purify daidzein	Genistein Genistein group were given 10g soy protein isolated and 50mg purify genistein
Overall Study STARTED	54	55	56
Overall Study COMPLETED	47	50	54
Overall Study NOT COMPLETED	7	5	2

Reasons for withdrawal

Measure	Placebo the placebo group were given 10g soy protein isolated without isoflavones	Daidzein Daidzein group were given 10g soy protein isolated and 50mg purify daidzein	Genistein Genistein group were given 10g soy protein isolated and 50mg purify genistein
Overall Study Lack of Efficacy	1	0	0
Overall Study Adverse Event	0	1	1
Overall Study Lost to Follow-up	2	2	0
Overall Study Physician Decision	1	0	1
Overall Study Withdrawal by Subject	1	1	0
Overall Study Other:Depression	1	0	0
Overall Study Other: Colon cancer	1	0	0
Overall Study Other: Stroke	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=54 Participants the placebo group were given 10g soy protein isolated without isoflavones	Daidzein n=55 Participants Daidzein group were given 10g soy protein isolated and 50mg purify daidzein	Genistein n=56 Participants Genistein group were given 10g soy protein isolated and 50mg purify genistein	Total n=165 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	43 Participants n=7 Participants	42 Participants n=5 Participants	128 Participants n=4 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	37 Participants n=4 Participants
Age Continuous	56.31 years STANDARD_DEVIATION 11.07 • n=5 Participants	56.36 years STANDARD_DEVIATION 9.90 • n=7 Participants	57.02 years STANDARD_DEVIATION 9.68 • n=5 Participants	56.57 years STANDARD_DEVIATION 10.17 • n=4 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	55 Participants n=7 Participants	56 Participants n=5 Participants	165 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment China	54 participants n=5 Participants	55 participants n=7 Participants	56 participants n=5 Participants	165 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline,6 months

Population: the number of participants for analysis was determined by intention to treat

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in Fasting Plasma Glucose	-1.80 percentage of change Standard Deviation 13.5	-1.00 percentage of change Standard Deviation 12.61	-4.89 percentage of change Standard Deviation 11.79

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: All participants were determinted by intention to treat

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in 120-minutes Postload Plasma Glucose	-4.90 percentage of change Standard Deviation 20.67	-3.13 percentage of change Standard Deviation 20.60	-5.59 percentage of change Standard Deviation 24.23

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants analyzed was determinted by intention to treat.

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in HbA1C	-1.38 percentage of change Standard Deviation 7.17	-1.37 percentage of change Standard Deviation 5.99	-1.30 percentage of change Standard Deviation 9.29

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of patticipants was determinted by intention to treat

values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in AUC of Glucose	-6.23 percentage of change Standard Deviation 14.06	-3.27 percentage of change Standard Deviation 16.98	-5.24 percentage of change Standard Deviation 17.96

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants was determinted by intention to treat

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in Fasting Plasma Insulin	25.27 percentage of change Standard Deviation 114.23	21.41 percentage of change Standard Deviation 91.23	6.06 percentage of change Standard Deviation 78.26

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants for analysis was determinted by intention to treat

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%

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in HOMA-IR	22.83 Percentage of change Standard Deviation 107.41	21.60 Percentage of change Standard Deviation 98.88	-0.22 Percentage of change Standard Deviation 64.03

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants for analysis was determinted by intention to treat

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%

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in QUICKI	2.32 Percentage of change Standard Deviation 19.47	0.18 Percentage of change Standard Deviation 15.60	6.29 Percentage of change Standard Deviation 17.77

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants for analysis was determinted by intention to treat

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in Total Cholesterol	2.85 Percentage of change Standard Deviation 40.06	-0.59 Percentage of change Standard Deviation 11.90	-0.64 Percentage of change Standard Deviation 15.83

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants for analysis was determinted by intention to treat

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in Triglyceride	5.93 Percentage of change Standard Deviation 45.50	3.43 Percentage of change Standard Deviation 38.90	-1.56 Percentage of change Standard Deviation 39.15

PRIMARY outcome

Timeframe: Baseline, 6 months

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in High Density Lipoprotein Cholesterol	3.18 Percentage of change Standard Deviation 20.40	1.36 Percentage of change Standard Deviation 15.21	2.15 Percentage of change Standard Deviation 14.54

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: The number of participants for analysis was determinted by intention to treat

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

Outcome measures

Measure	Placebo Group n=54 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=55 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=56 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Percentage Change in Low Density Lipoprotein Cholesterol	1.08 Percentage of change Standard Deviation 24.46	-0.93 Percentage of change Standard Deviation 21.21	1.86 Percentage of change Standard Deviation 19.39

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants for analysis was determinted by the participants who provided the urine samples at the 3-month test.

Outcome measures

Measure	Placebo Group n=46 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=52 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=50 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Total Urinary Isoflavones	8.538 ug/ml Standard Deviation 10.153	25.818 ug/ml Standard Deviation 31.780	15.467 ug/ml Standard Deviation 22.022

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants for analysis was determinted by the number of participants who provided urine samples at the 3-month test

Urinary daidzein excretion

Outcome measures

Measure	Placebo Group n=46 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=52 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=50 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Urinary Daidzein	3.34 ug/ml Standard Deviation 4.81	11.80 ug/ml Standard Deviation 11.14	3.73 ug/ml Standard Deviation 8.83

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants for analysis was determinted by the number of participants who supplied the urine samples at the 3-month test

Urinary genistein excretion

Outcome measures

Measure	Placebo Group n=46 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=52 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=50 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Urinary Genistein	1.32 ug/ml Standard Deviation 1.72	1.89 ug/ml Standard Deviation 2.59	6.54 ug/ml Standard Deviation 8.97

SECONDARY outcome

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

Population: The number of participants for analysis was determinted by intention to treat

The energy intake was evaluated by 3 days dietary records.

Outcome measures

Measure	Placebo Group n=47 Participants All participants were received 10g soy protein isolated without isoflavones daily	Daidzein Group n=50 Participants All participants were received 10g soy protein isolated plus 50mg purify daidzein daily	Geinstein Group n=54 Participants All participants were received 10g soy protein isolated plus 50mg purify genistein daily
Total Energy Intake at Follow-up	1575 kcal Standard Deviation 575	1473 kcal Standard Deviation 294	1579 kcal Standard Deviation 367

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Daidzein

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Genistein

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=54 participants at risk the placebo group were given 10g soy protein isolated without isoflavones	Daidzein n=55 participants at risk Daidzein group were given 10g soy protein isolated and 50mg purify daidzein	Genistein n=56 participants at risk Genistein group were given 10g soy protein isolated and 50mg purify genistein
Reproductive system and breast disorders vignal bleeding	1.9% 1/54 • Number of events 1 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	1.8% 1/55 • Number of events 1 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	0.00% 0/56 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.
Endocrine disorders hyperplasia of mammary glands	1.9% 1/54 • Number of events 1 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	0.00% 0/55 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	0.00% 0/56 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.
Renal and urinary disorders proteinuria	0.00% 0/54 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	0.00% 0/55 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	1.8% 1/56 • Number of events 1 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.
Gastrointestinal disorders thirsty	3.7% 2/54 • Number of events 2 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	3.6% 2/55 • Number of events 2 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	1.8% 1/56 • Number of events 1 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.
Gastrointestinal disorders flatulence	0.00% 0/54 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	1.8% 1/55 • Number of events 1 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.	0.00% 0/56 • We collected 10 cases of other adverse events which were mild to moderate in severity in the 6 months intervention period.

Additional Information

Dr. Yan-bin Ye

the First Affiliated Hospital of Sun Yat-sen University

Phone: 8620-87755766

Email: yanbinye72@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place