Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 3:28 PM
Study NCT ID:
NCT07086833
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities
Sponsor:
Purdue University
Organization:
Study Overview
Official Title:
The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
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:
The goal of this clinical trial is to learn if changing cysteine levels in the diet can influence how the body processes cysteine in Black and White individuals aged 45-75 with a history of non-cancerous polyps. The main questions it aims to answer are:
* At the beginning of the study, do Black participants have higher levels of cortisol (a stress hormone) and compounds made from cysteine in their blood when compared to White participants?
* Does eating less cysteine lower the body's natural cysteine activity and lead to less gut bacteria that break down cysteine?
* Does eating less cysteine lead to less inflammation in the gut and lower levels of markers of inflammation in the blood?
Research will compare a high cysteine diet and a low cysteine diet, and each participant will eat both diets.
Participants will be in the study for 11 weeks and 2 days. Over the course of the study, participants will:
* Eat a high cysteine diet for 3 weeks, and a low cysteine diet for 3 weeks
* Eat a moderate cysteine diet for 1 week before each study diet
* Complete surveys
* Provide blood, stool, and saliva samples
* Maintain food logs
* At the beginning of the study, do Black participants have higher levels of cortisol (a stress hormone) and compounds made from cysteine in their blood when compared to White participants?
* Does eating less cysteine lower the body's natural cysteine activity and lead to less gut bacteria that break down cysteine?
* Does eating less cysteine lead to less inflammation in the gut and lower levels of markers of inflammation in the blood?
Research will compare a high cysteine diet and a low cysteine diet, and each participant will eat both diets.
Participants will be in the study for 11 weeks and 2 days. Over the course of the study, participants will:
* Eat a high cysteine diet for 3 weeks, and a low cysteine diet for 3 weeks
* Eat a moderate cysteine diet for 1 week before each study diet
* Complete surveys
* Provide blood, stool, and saliva samples
* Maintain food logs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RSG-23-1154989-01-CSCT | OTHER_GRANT | American Cancer Society | View |