Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-31 @ 12:37 AM
Study NCT ID:
NCT01073969
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women
Sponsor:
Kellogg Company
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Controlled Crossover Trial to Assess the Digestive and Physiological Effects of a Wheat Bran Extract in Healthy Men and Women
Status:
COMPLETED
Status Verified Date:
2010-02
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 primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: