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

February 22, 2010 updated by: Kellogg Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: Baseline to end of each treatment (week 0 to week 3 of each treatment)
Baseline to end of each treatment (week 0 to week 3 of each treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Other fecal bacterial counts
Time Frame: baseline to end of each treatment (week 0 to week 3 of each treatment)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
baseline to end of each treatment (week 0 to week 3 of each treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kellogg Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tufts University
University of Toronto
University of Saskatchewan
University of Reading
Provident Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kevin Maki, PhD, Provident Clinical Research and Consulting, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRV-08011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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