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

Purpose

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.

Condition	Intervention	Phase
Healthy	Other: wheat bran extract Other: control wheat bran extract	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Bowel Movement Diabetes Medicines

U.S. FDA Resources

Further study details as provided by Kellogg Company:

Primary Outcome Measures:

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) [ Time Frame: Baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other fecal bacterial counts [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
laxation [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
fecal pH [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
fecal moisture [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
stool consistency [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
blood glucose [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
Blood insulin [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
plasma lipid profiles [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
serum free fatty acids [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
fecal short chain fatty acids [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
fecal ammonia [ Time Frame: baseline to end of each treament (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
urinary para-cresol [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
urinary phenol (total) [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
urinary isoprostanes [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
oxidized low density lipoprotein (TBARS, conjugated dienes) [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
Urinary F2alpha-isoprostanes [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
Plasma antioxidant capacity (ORAC, FRAP) [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
serum amyloid A [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
hs-CRP [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
IL-6 [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
TNF-alpha [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
gastrointestinal symptom survey [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
stool consistency (Bristol stool scale) [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]
Quality of Life questionaire (Quality Metrics SF-36) [ Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment) ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	March 2009
Study Completion Date:	August 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073969

Locations

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

Sponsors and Collaborators

Kellogg Company

Provident Clinical Research

Tufts University

University of Toronto

University of Reading

University of Saskatchewan

Investigators

Study Director:

Kevin Maki, PhD

Provident Clinical Research and Consulting, Inc

More Information

No publications provided

Responsible Party:	Robin Dickmann, Senior Nutrition Scientist, Kellogg Company
ClinicalTrials.gov Identifier:	NCT01073969 History of Changes
Other Study ID Numbers:	PRV-08011
Study First Received:	February 19, 2010
Last Updated:	February 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Kellogg Company:

prebiotic study
modulating colonic bacteria

ClinicalTrials.gov processed this record on June 17, 2013