Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-30 @ 9:56 AM
Study NCT ID:
NCT01698294
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Post-Menopausal Women Receiving Flaxseed
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
Status:
COMPLETED
Status Verified Date:
2022-05
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:
This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.
II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).
III. To determine how these associations differ by race (i.e., African American and European American women).
OUTLINE: Participants are randomized to 1 of 2 treatment groups.
GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
After completion of study treatment, participants are followed up for 30 days.
I. To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.
II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).
III. To determine how these associations differ by race (i.e., African American and European American women).
OUTLINE: Participants are randomized to 1 of 2 treatment groups.
GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.
GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.
After completion of study treatment, participants are followed up for 30 days.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01246 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 216812 | OTHER | Roswell Park Cancer Institute | View | |
| U01CA161809 | NIH | None | https://reporter.nih.gov/quic… | View |