NCT01073969

Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Kellogg Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	wheat bran extract	Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract
OTHER	control wheat bran extract	Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2010-02-23
• Last updated: 2010-02-23

Locations

1 site across 1 country: United States