Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003100
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Dietary Soy Isoflavones for the Prevention of Cancer
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Metabolic Fate and Plasma Kinetics of Dietary Soy Isoflavones
Status:
UNKNOWN
Status Verified Date:
2000-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Eating a diet rich in soy foods appears to reduce the risk of some types of cancer Isoflavones are compounds found in soy food that may prevent the development of cancer
PURPOSE Clinical trial to determine the most effective amount and type of soy isoflavones needed in the diets of healthy men and women to prevent cancer
PURPOSE Clinical trial to determine the most effective amount and type of soy isoflavones needed in the diets of healthy men and women to prevent cancer
Detailed Description:
OBJECTIVES I Determine the effect of varying the dietary intake of soy nuts on plasma levels and urinary excretion of isoflavones II Determine the effects of different food composition along with age and gender of subjects on plasma levels and urinary excretion of isoflavones
OUTLINE This is a two part study In part I participants are stratified according to menopausal status In part II participants are stratified according to gender and age under 50 vs over 50 Part I - Study participants are given 3 different amounts of toasted soy nuts separated by one month intervals The sequence in which each amount is given is randomized Blood and urine samples are taken to measure isoflavone levels Part II - Study participants are given toasted soy nuts soy milk and tempeh on separate occasions separated by one month intervals The sequence of each food is randomized Blood and urine samples are taken to measure isoflavone levels
PROJECTED ACCRUAL 10 women 5 premenopausal and 5 postmenopausal will be accrued for part I of the study 80 subjects 40 women and 40 men will be accrued for part II
OUTLINE This is a two part study In part I participants are stratified according to menopausal status In part II participants are stratified according to gender and age under 50 vs over 50 Part I - Study participants are given 3 different amounts of toasted soy nuts separated by one month intervals The sequence in which each amount is given is randomized Blood and urine samples are taken to measure isoflavone levels Part II - Study participants are given toasted soy nuts soy milk and tempeh on separate occasions separated by one month intervals The sequence of each food is randomized Blood and urine samples are taken to measure isoflavone levels
PROJECTED ACCRUAL 10 women 5 premenopausal and 5 postmenopausal will be accrued for part I of the study 80 subjects 40 women and 40 men will be accrued for part II
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P97-0117 | None | None | None |
| UCMC-CHMC-91-5-3 | None | None | None |