HealthyPhase 4NCT01073969
Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women
A Phase 4 study testing wheat bran extract in people with Healthy, run by Kellogg Company at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- wheat bran extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- wheat bran extract, control wheat bran extract
- Keywords
- prebiotic study, modulating colonic bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat bran extractOther
Also called wheat bran oligosccharides, prebiotic oligosccharides
Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract
control wheat bran extractOther
Also called wheat bran oligosccharides, prebiotic oligosccharides
Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract
| Study group | Role | What they receive |
|---|---|---|
| Control cereal | Placebo comparator | grain-based ready to eat cereal that does not contain active wheat bran extract Receives: Other: control wheat bran extract |
| low dose | Active comparator | grain-based ready to eat cereal containing a low dose of wheat bran extract Receives: Other: wheat bran extract |
| High dose | Active comparator | grain-based ready to eat cereal that contains a high dose of wheat bran extract Receives: Other: wheat bran extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to end of each treatment (week 0 to week 3 of each treatment)
Secondary outcomes (24)
Other fecal bacterial counts
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
laxation
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal pH
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal moisture
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
stool consistency
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
blood glucose
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
Blood insulin
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
plasma lipid profiles
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
serum free fatty acids
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal short chain fatty acids
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
fecal ammonia
Measured: baseline to end of each treament (week 0 to week 3 of each treatment)
urinary para-cresol
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
urinary phenol (total)
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
urinary isoprostanes
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
oxidized low density lipoprotein (TBARS, conjugated dienes)
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
Urinary F2alpha-isoprostanes
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
Plasma antioxidant capacity (ORAC, FRAP)
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
serum amyloid A
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
hs-CRP
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
IL-6
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
TNF-alpha
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
gastrointestinal symptom survey
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
stool consistency (Bristol stool scale)
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
Quality of Life questionaire (Quality Metrics SF-36)
Measured: baseline to end of each treatment (week 0 to week 3 of each treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kellogg Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research, Tufts University, University of Toronto, University of Reading, University of Saskatchewan
- Investigators
- Kevin Maki, PhD, Study director, Provident Clinical Research and Consulting, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073969
- Sponsor's protocol ID
- PRV-08011
- Status last verified
- Feb 2010
- First submitted
- 19 Feb 2010
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01073969
- Acronym / sponsor ID
- PRV-08011
- Conditions
- Healthy
- Keywords
- prebiotic study, modulating colonic bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kellogg CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research, Tufts University, University of Toronto, University of Reading, University of Saskatchewan
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control cereal | Placebo comparator | Other: control wheat bran extractgrain-based ready to eat cereal that does not contain active wheat bran extract |
| low dose | Active comparator | Other: wheat bran extractgrain-based ready to eat cereal containing a low dose of wheat bran extract |
| High dose | Active comparator | Other: wheat bran extractgrain-based ready to eat cereal that contains a high dose of wheat bran extract |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Significant gastrointestinal condition
- Use of pre/probiotic foods or supplements
- Use of antibiotics
- Pregnancy
- Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wheat bran extractAlso: wheat bran oligosccharides, prebiotic oligosccharidesComparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract | Other | High dose, low dose |
| control wheat bran extractAlso: wheat bran oligosccharides, prebiotic oligosccharidesComparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract | Other | Control cereal |
Primary outcome
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)
24 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Maki, PhD study director
Provident Clinical Research and Consulting, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing wheat bran extract in people with Healthy, run by Kellogg Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2010.