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

This study has been completed.
Sponsor:
Collaborators:
Provident Clinical Research
Tufts University
University of Toronto
University of Reading
University of Saskatchewan
Information provided by:
Kellogg Company
ClinicalTrials.gov Identifier:
NCT01073969
First received: February 19, 2010
Last updated: February 22, 2010
Last verified: February 2010
  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:


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 April 15, 2014