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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: control wheat bran extract; Other: wheat bran extract

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Glen Ellyn, Illinois, United States, 60137
      • Provident CRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female
• 18-75 years of age
• Body mass index ≥18.5 and <35.0 kg/m2
• Fasting LDL-C level ≥100 mg/dL and <200 mg/dL
• Otherwise judged to be in good health, willing to maintain habitual food and beverage intake and physical activity patterns throughout the trial

Exclusion Criteria:

• Significant gastrointestinal condition
• Use of pre/probiotic foods or supplements
• Use of antibiotics
• Pregnancy
• Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
• Poorly controlled hypertension
• Cancer treated within prior 2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control cereal; grain-based ready to eat cereal that does not contain active 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; Other Names: wheat bran oligosccharides; prebiotic oligosccharides
Active Comparator: low dose; grain-based ready to eat cereal containing a low dose of wheat bran extract	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 Names: wheat bran oligosccharides; prebiotic oligosccharides
Active Comparator: High dose; grain-based ready to eat cereal that contains a high dose of wheat bran extract	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 Names: wheat bran oligosccharides; prebiotic oligosccharides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight)	Baseline to end of each treatment (week 0 to week 3 of each treatment)

Secondary Outcome Measures

Outcome Measure	Time Frame
Other fecal bacterial counts	baseline to end of each treatment (week 0 to week 3 of each treatment)
laxation	baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal pH	baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal moisture	baseline to end of each treatment (week 0 to week 3 of each treatment)
stool consistency	baseline to end of each treatment (week 0 to week 3 of each treatment)
blood glucose	baseline to end of each treatment (week 0 to week 3 of each treatment)
Blood insulin	baseline to end of each treatment (week 0 to week 3 of each treatment)
plasma lipid profiles	baseline to end of each treatment (week 0 to week 3 of each treatment)
serum free fatty acids	baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal short chain fatty acids	baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal ammonia	baseline to end of each treament (week 0 to week 3 of each treatment)
urinary para-cresol	baseline to end of each treatment (week 0 to week 3 of each treatment)
urinary phenol (total)	baseline to end of each treatment (week 0 to week 3 of each treatment)
urinary isoprostanes	baseline to end of each treatment (week 0 to week 3 of each treatment)
oxidized low density lipoprotein (TBARS, conjugated dienes)	baseline to end of each treatment (week 0 to week 3 of each treatment)
Urinary F2alpha-isoprostanes	baseline to end of each treatment (week 0 to week 3 of each treatment)
Plasma antioxidant capacity (ORAC, FRAP)	baseline to end of each treatment (week 0 to week 3 of each treatment)
serum amyloid A	baseline to end of each treatment (week 0 to week 3 of each treatment)
hs-CRP	baseline to end of each treatment (week 0 to week 3 of each treatment)
IL-6	baseline to end of each treatment (week 0 to week 3 of each treatment)
TNF-alpha	baseline to end of each treatment (week 0 to week 3 of each treatment)
gastrointestinal symptom survey	baseline to end of each treatment (week 0 to week 3 of each treatment)
stool consistency (Bristol stool scale)	baseline to end of each treatment (week 0 to week 3 of each treatment)
Quality of Life questionaire (Quality Metrics SF-36)	baseline to end of each treatment (week 0 to week 3 of each treatment)

Collaborators and Investigators

• Sponsor: Kellogg Company
• Collaborators: Tufts University; University of Toronto; University of Saskatchewan; University of Reading; Provident Clinical Research
• Investigators: Study Director: Kevin Maki, PhD, Provident Clinical Research and Consulting, Inc

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: February 19, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): February 23, 2010
• Last Update Submitted That Met QC Criteria: February 22, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: prebiotic study; modulating colonic bacteria
• Other Study ID Numbers: PRV-08011