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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073969
First Posted: February 23, 2010
Last Update Posted: February 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Provident Clinical Research
Tufts University
University of Toronto
University of Reading
University of Saskatchewan
Information provided by:
Kellogg Company
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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

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) ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Robin Dickmann, Senior Nutrition Scientist, Kellogg Company
ClinicalTrials.gov Identifier: NCT01073969     History of Changes
Other Study ID Numbers: PRV-08011
First Submitted: February 19, 2010
First Posted: February 23, 2010
Last Update Posted: February 23, 2010
Last Verified: February 2010

Keywords provided by Kellogg Company:
prebiotic study
modulating colonic bacteria