Bio-availability of Wheat Bran Phytochemicals in the Human GutWB2001NCT02177279
Bioactive Phytochemicals From Wheat Bran
A study testing Visit A high wheat bran, Visit B normal wheat bran and Follow up normal (8days) and high (1day) bran consumption in people with Bio-availability of Wheat Bran Phytochemicals in the Human Gut and Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bio-availability of Wheat Bran Phytochemicals in the Human Gut, Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation
- What is being tested?
- Visit A high wheat bran, Visit B normal wheat bran and Follow up normal (8days) and high (1day) bran consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Feb 2013
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers will be healthy males or females and aged between 18 and 55 years who have a documented low (less than 1 portion per week) or high (more than or equal 5 portions per week) consumption of wheat bran and are able to give informed consent.
Who cannot join
- are taking any medicines prescribed by their general practitioner
- are taking drugs to lower high cholesterol levels or high blood pressure
- regularly take analgesics, antipyretic or anti-inflammatories
- regularly take nutritional supplements
- have taken antibiotics in the last three months
- have given a large blood donation in last three months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, Aberdeenshire, AB21 9SB
About this study
Official title: Identification of Novel Bioactive Compounds in Wheat Bran
There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It is still not clear exactly why this happens, but it is likely that the compounds which enter our bodies when we eat such products are responsible. In this study we plan to find out what these compounds are and where they are found. The investigators will do this by asking volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood, urine and stool samples over the next twenty-four hours. Once the investigators know how much and which compounds are present, we can then find out possible reasons why they are protective, for example by looking to see whether they are anti-inflammatory. We also plan to look at whether if having a diet which contains either a lot of wheat-bran products or very low amounts of these foods effects how they are absorbed by the body.
HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are metabolized to compounds responsible for high cellular bioactivity imparting important health benefits.
- Conditions
- Bio-availability of Wheat Bran Phytochemicals in the Human Gut, Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation
- Being tested
- Visit A high wheat bran, Visit B normal wheat bran, Follow up normal (8days) and high (1day) bran consumption
- Keywords
- Wheat bran cereals, bran phytochemicals, phytochemicals bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visit A high wheat branOther
Visit B normal wheat branOther
Follow up normal (8days) and high (1day) bran consumptionOther
| Study group | Role | What they receive |
|---|---|---|
| Visit A- 120g wheat bran cereals | Other | A morning vist where volunteers consumed 120g of wheat bran cereals with 125ml semi-skimmed milk Receives: Other: Visit A high wheat bran |
| Visit B-40g wheat bran cereals | Other | A morning vist where volunteers consumed 40g of wheat bran cereals with 375 ml semi-skimmed milk Receives: Other: Visit B normal wheat bran |
| Follow up-40g (8days), 120g (1day) wheat bran cereals | Other | Volunteers follow their normal diet but they were asked to consume 40g wheat bran cereals with 125 ml semi-skimmed milk for eight days and on day nine 120g wheat bran cereals with 375ml semi-skimmed milk Receives: Other: Follow up normal (8days) and high (1day) bran consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human bioavailability of benzoic acids and derivatives from wheat bran cereals
The analysis of the benzoic acid and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24 h
Human bioavailability of cinnamic acids and derivatives from wheat bran cereals
The analysis of the cinnamic acids and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24h
Human bioavailability of phenylpropanoid dimers from wheat bran cereals
The analysis of the phenylpropanoid dimers metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24h
Human bioavailability of phenyl propionic acids from wheat bran cereals
The analysis of the phenyl propionic acids metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24h
Bioavailability of benzaldehydes from wheat bran
The analysis of the benzaldehydes metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24h
Human bioavailability of acetophenones from wheat bran cereals
The analysis of the acetophenones metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24h
Human bioavailability of lignans from wheat bran cereals
The analysis of the lignans metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Measured: over 24 h
Short chain fatty acids profile after wheat bran consumption (acute)
Short chain fatty acids profile in faecal samples at 0h (baseline) and 24h after wheat bran consumption (40g and 120g).
Measured: 24 h
Short chain fatty acids profile after wheat bran consumption (chronic)
Short chain fatty acids profile in in faecal samples at day 0 (baseline), day 5 (during 7 days consumption of 40g wheat bran cereals/day) and day 10 (after 120g wheat bran cereals consumption on day 9).
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bio-availability of Wheat Bran Phytochemicals in the Human GutStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Kellogg Company
- Responsible party
- Sponsor
- Investigators
- Wendy R Russell, PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of AberdeenBaukje de Roos, PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of AberdeenGarry Duthie, Professor, Principal investigator, Rowett Institute of Nutrition and Health, University of AberdeenJolene McMonagle, PhD, Principal investigator, Kellogg CompanyReg Fletcher, PhD, Principal investigator, Kellogg Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177279
- Sponsor's protocol ID
- Wheat Bran 2001
- Acronym
- WB2001
- Status last verified
- Jul 2014
- First submitted
- 19 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Novel Bioactive Compounds in Wheat Bran
- ClinicalTrials.gov ID
- NCT02177279
- Acronym / sponsor ID
- WB2001 / Wheat Bran 2001
- Conditions
- Bio-availability of Wheat Bran Phytochemicals in the Human Gut, Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation
- Keywords
- Wheat bran cereals, bran phytochemicals, phytochemicals bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Kellogg Company
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- First posted
- 27 Jun 2014 (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.
There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It is still not clear exactly why this happens, but it is likely that the compounds which enter our bodies when we eat such products are responsible. In this study we plan to find out what these compounds are and where they are found. The investigators will do this by asking volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood, urine and stool samples over the next twenty-four hours. Once the investigators know how much and which compounds are present, we can then find out possible reasons why they are protective, for example by looking to see whether they are anti-inflammatory. We also plan to look at whether if having a diet which contains either a lot of wheat-bran products or very low amounts of these foods effects how they are absorbed by the body.
HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are metabolized to compounds responsible for high cellular bioactivity imparting important health benefits.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Visit A- 120g wheat bran cereals | Other | Other: Visit A high wheat branA morning vist where volunteers consumed 120g of wheat bran cereals with 125ml semi-skimmed milk |
| Visit B-40g wheat bran cereals | Other | Other: Visit B normal wheat branA morning vist where volunteers consumed 40g of wheat bran cereals with 375 ml semi-skimmed milk |
| Follow up-40g (8days), 120g (1day) wheat bran cereals | Other | Other: Follow up normal (8days) and high (1day) bran consumptionVolunteers follow their normal diet but they were asked to consume 40g wheat bran cereals with 125 ml semi-skimmed milk for eight days and on day nine 120g wheat bran cereals with 375ml semi-skimmed milk |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers will be healthy males or females and aged between 18 and 55 years who have a documented low (less than 1 portion per week) or high (more than or equal 5 portions per week) consumption of wheat bran and are able to give informed consent.
Key exclusion criteria (6 listed)
- are taking any medicines prescribed by their general practitioner
- are taking drugs to lower high cholesterol levels or high blood pressure
- regularly take analgesics, antipyretic or anti-inflammatories
- regularly take nutritional supplements
- have taken antibiotics in the last three months
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 |
|---|---|---|
| Visit A high wheat bran | Other | Visit A- 120g wheat bran cereals |
| Visit B normal wheat bran | Other | Visit B-40g wheat bran cereals |
| Follow up normal (8days) and high (1day) bran consumption | Other | Follow up-40g (8days), 120g (1day) wheat bran cereals |
Primary outcome
Human bioavailability of benzoic acids and derivatives from wheat bran cereals
Time frame: over 24 h
The analysis of the benzoic acid and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Human bioavailability of cinnamic acids and derivatives from wheat bran cereals
Time frame: over 24h
The analysis of the cinnamic acids and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Human bioavailability of phenylpropanoid dimers from wheat bran cereals
Time frame: over 24h
The analysis of the phenylpropanoid dimers metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Human bioavailability of phenyl propionic acids from wheat bran cereals
Time frame: over 24h
The analysis of the phenyl propionic acids metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Bioavailability of benzaldehydes from wheat bran
Time frame: over 24h
The analysis of the benzaldehydes metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Human bioavailability of acetophenones from wheat bran cereals
Time frame: over 24h
The analysis of the acetophenones metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Human bioavailability of lignans from wheat bran cereals
Time frame: over 24 h
The analysis of the lignans metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h).
Short chain fatty acids profile after wheat bran consumption (acute)
Time frame: 24 h
Short chain fatty acids profile in faecal samples at 0h (baseline) and 24h after wheat bran consumption (40g and 120g).
Short chain fatty acids profile after wheat bran consumption (chronic)
Time frame: 9 days
Short chain fatty acids profile in in faecal samples at day 0 (baseline), day 5 (during 7 days consumption of 40g wheat bran cereals/day) and day 10 (after 120g wheat bran cereals consumption on day 9).
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 8 Jul 2014.
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.
Wendy R Russell, PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen
Baukje de Roos, PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen
Garry Duthie, Professor principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visit A high wheat bran, Visit B normal wheat bran and Follow up normal (8days) and high (1day) bran consumption in people with Bio-availability of Wheat Bran Phytochemicals in the Human Gut and Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation, run by University of Aberdeen at 1 site in United Kingdom.
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 1 inclusion and 6 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 8 Jul 2014. 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 Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Human bioavailability of benzoic acids and derivatives from wheat bran cereals (time frame: over 24 h). The study lists 9 primary outcomes in all. 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 8 Jul 2014.