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

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

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

Sponsors & Collaborators

• Provident Clinical Research

  collaborator OTHER

• Tufts University

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• University of Reading

  collaborator OTHER

• University of Saskatchewan

  collaborator OTHER

• Kellogg Company

  lead INDUSTRY

Principal Investigators

• Kevin Maki, PhD · Provident Clinical Research and Consulting, Inc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2009-07-31

Completion

2009-08-31

Countries

• United States

Study Locations