Healthy MalesNCT00777543
Increasing Ferulic Acid Bioavailability in Bran
A study testing ferulic acid, Treated bran bread and wholegrain bread in people with Healthy Males, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of the present study is to investigate the effect of pretreatment of bran on improving the bioavailability of ferulic acid in wholegrain breads containing bran. As secondary endpoints we will investigate the changes in plasmatic antioxidant capacity, anti-inflammatory effects, colonic metabolites from ferulic… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- What is being tested?
- ferulic acid, Treated bran bread and wholegrain bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2008to Dec 2009
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Age > 18
- 20 < BMI < 30
Who cannot join
- Use of any medication
- Smoking
- Consumption of 3 or more glasses of alcoholic drinks per day
- Donation of more than 500 ml blood (<6 months prior to the start of the study)
- Vegetarian lifestyle (because the standardised meal contains meat)
- Allergic reaction to some component in cereals e.g. celiac subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-treatment of Bran on the Bioavailability of Ferulic Acid and Other Bioactive Compounds From Wholegrain Breads Enriched in Bran
The aim of the present study is to investigate the effect of pretreatment of bran on improving the bioavailability of ferulic acid in wholegrain breads containing bran. As secondary endpoints we will investigate the changes in plasmatic antioxidant capacity, anti-inflammatory effects, colonic metabolites from ferulic acid and short chain fatty acids (SCFA).
Read the detailed description
Rationale: Whole grain consumption has been associated with a lower risk of developing metabolic syndrome, cardiovascular disease, type 2 diabetes and some type of cancers. Whole grain is a good source of antioxidant compounds such as ferulic acid, which has been considered its major antioxidant. Ferulic acid is also the major phenolic compound in wheat grain, it is mainly located in the bran, more precisely in the cell walls of the aleurone layer and overall bran layers. Most of the ferulic acid is covalently bound to the indigestible cell wall polysaccharides, which limits the bioavailability of ferulic acid from cereal products to the merely form of free ferulic acid.
Processing possibilities in the development of cereal products might be used to optimize the bioavailability of ferulic acid in humans and the possible health effect of the wholegrain product.
An innovative processing in bread making has been developed. The processing consisted of pretreatments of the bran with an enzymatic mixture and yeast fermentation before its incorporation into the dough. The impact on the in vitro assessed bioavailability of ferulic acid was a 5-fold increase over the normal bran enriched wholegrain bread in a gastrointestinal model. Therefore in our study we will compare the kinetics and total bioavailability of ferulic acid from wholegrain breads enriched in native or pretreated bran. Furthermore, the colonic metabolism of ferulic acid and overall major colonic metabolites such as short chain fatty acids (SCFA) will be studied. Finally, total antioxidant capacity and ex vivo inflammatory responses will be investigated in order to determine the effect of the pretreatment of on the immunomodulatory properties of bran.
Objective: The aim of the present study is to investigate the effect of pretreatment of bran on improving the bioavailability of ferulic acid. As secondary endpoints we will investigate the changes in plasmatic antioxidant capacity, anti-inflammatory effects, colonic metabolites from ferulic acid and short chain fatty acids (SCFA).
Study design: Blind, cross-over, randomised design. Wash-out period of one week. Three days of low antioxidant diet. Standardised meal low in phenolic and antioxidant compounds will be consumed the evening before the trial.
Study population: Healthy male volunteers, > 18 yr old, BMI between 20 and 30. Intervention: Consumption of 300 g of wholegrain enriched with native or pretreated bran.
Main study parameters/endpoints: Ferulic acid and other phenolic acids (sinapic acid, p-coumaric acid), total antioxidant capacity, anti-inflammatory effects, colonic metabolites derived from ferulic acid and SCFA.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each volunteer will participate in the study on two separate occasions (each test will take approximately 24 hours). Blood will be drawn at different time points via a catheter (in total 156 ml per test-day) and a 24-hour urine sample will be collected. Participants are asked to consume a standardised meal the evening before each of the two test-days and the evening of the intervention day. Volunteers are instructed not to consume any wholegrain or bran containing products, nuts and seeds, antioxidant supplements or beverages high in phenolic compounds or any phenolic rich food for 3 days before each of the three trials. Subjects are asked to record their food intake for 3 days before each of the trials. All the ingredients used in the bread baking are safe for human consumption. The bread is consumed once at the beginning of the test. The volunteers will not benefit from the study. The major risk of the study is the amount of blood take from the volunteer and this risk is limited.
- Conditions
- Healthy Males
- Being tested
- ferulic acid, Treated bran bread, wholegrain bread
- Keywords
- Bioavailability, Ferulic acid, Phenolic compounds, Colonic metabolites, Immunomodulatory effects, No disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferulic acidOther
Also called Wholegrain bread, Bran, 4-hydroxy-3-methoxycinnamic acid
Ferulic acid is naturally contained in wholegrain bread. Bran is the main source of ferulic acid while is low in white flour. Ferulic acid is mainly covalently bound to fiber and low bioaccessible. The bran is pretreated to increase the bioavailability of ferulic acid by increasing the free ferulic acid released from the food matrix.
Treated bran breadDietary supplement
This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation
wholegrain breadDietary supplement
The control is the wholegrain bread enriched with bran that has not been pretreated
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The control is the wholegrain bread enriched with bran that has not been pretreated. Receives: Other: ferulic acid; Dietary Supplement: wholegrain bread |
| Treated bran bread | Experimental | This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation Receives: Other: ferulic acid; Dietary Supplement: Treated bran bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ferulic acid is measured in plasma to determine maximal concentration (Cmax), time-point of Cmax (tmax) and area under the curve (AUC). Ferulic acid is also measured in 24-hour urine sample to determine its excretion.
Measured: 24 h
Secondary outcomes (1)
Colonic metabolites derived from ferulic acid, short chain fatty acids and antioxidant capacity are measured in plasma to determine their relation with the plasma levels of ferulic acid. Cytokines will be measured in ex vivo LPS stimulated blood.
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MalesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aalt Bast, Professor, Principal investigator, Universit of Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777543
- Sponsor's protocol ID
- 08-3-079
- Other IDs
- NL26116.068.08
- Status last verified
- Nov 2009
- First submitted
- 16 Oct 2008
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-treatment of Bran on the Bioavailability of Ferulic Acid and Other Bioactive Compounds From Wholegrain Breads Enriched in Bran
- ClinicalTrials.gov ID
- NCT00777543
- Acronym / sponsor ID
- 08-3-079
- Conditions
- Healthy Males
- Keywords
- Bioavailability, Ferulic acid, Phenolic compounds, Colonic metabolites, Immunomodulatory effects, No disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Oct 2008 (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 aim of the present study is to investigate the effect of pretreatment of bran on improving the bioavailability of ferulic acid in wholegrain breads containing bran. As secondary endpoints we will investigate the changes in plasmatic antioxidant capacity, anti-inflammatory effects, colonic metabolites from ferulic acid and short chain fatty acids (SCFA).
Detailed description
Rationale: Whole grain consumption has been associated with a lower risk of developing metabolic syndrome, cardiovascular disease, type 2 diabetes and some type of cancers. Whole grain is a good source of antioxidant compounds such as ferulic acid, which has been considered its major antioxidant. Ferulic acid is also the major phenolic compound in wheat grain, it is mainly located in the bran, more precisely in the cell walls of the aleurone layer and overall bran layers. Most of the ferulic acid is covalently bound to the indigestible cell wall polysaccharides, which limits the bioavailability of ferulic acid from cereal products to the merely form of free ferulic acid.
Processing possibilities in the development of cereal products might be used to optimize the bioavailability of ferulic acid in humans and the possible health effect of the wholegrain product.
An innovative processing in bread making has been developed. The processing consisted of pretreatments of the bran with an enzymatic mixture and yeast fermentation before its incorporation into the dough. The impact on the in vitro assessed bioavailability of ferulic acid was a 5-fold increase over the normal bran enriched wholegrain bread in a gastrointestinal model. Therefore in our study we will compare the kinetics and total bioavailability of ferulic acid from wholegrain breads enriched in native or pretreated bran. Furthermore, the colonic metabolism of ferulic acid and overall major colonic metabolites such as short chain fatty acids (SCFA) will be studied. Finally, total antioxidant capacity and ex vivo inflammatory responses will be investigated in order to determine the effect of the pretreatment of on the immunomodulatory properties of bran.
Objective: The aim of the present study is to investigate the effect of pretreatment of bran on improving the bioavailability of ferulic acid. As secondary endpoints we will investigate the changes in plasmatic antioxidant capacity, anti-inflammatory effects, colonic metabolites from ferulic acid and short chain fatty acids (SCFA).
Study design: Blind, cross-over, randomised design. Wash-out period of one week. Three days of low antioxidant diet. Standardised meal low in phenolic and antioxidant compounds will be consumed the evening before the trial.
Study population: Healthy male volunteers, > 18 yr old, BMI between 20 and 30. Intervention: Consumption of 300 g of wholegrain enriched with native or pretreated bran.
Main study parameters/endpoints: Ferulic acid and other phenolic acids (sinapic acid, p-coumaric acid), total antioxidant capacity, anti-inflammatory effects, colonic metabolites derived from ferulic acid and SCFA.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each volunteer will participate in the study on two separate occasions (each test will take approximately 24 hours). Blood will be drawn at different time points via a catheter (in total 156 ml per test-day) and a 24-hour urine sample will be collected. Participants are asked to consume a standardised meal the evening before each of the two test-days and the evening of the intervention day. Volunteers are instructed not to consume any wholegrain or bran containing products, nuts and seeds, antioxidant supplements or beverages high in phenolic compounds or any phenolic rich food for 3 days before each of the three trials. Subjects are asked to record their food intake for 3 days before each of the trials. All the ingredients used in the bread baking are safe for human consumption. The bread is consumed once at the beginning of the test. The volunteers will not benefit from the study. The major risk of the study is the amount of blood take from the volunteer and this risk is limited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ferulic acid, Dietary Supplement: wholegrain breadThe control is the wholegrain bread enriched with bran that has not been pretreated. |
| Treated bran bread | Experimental | Other: ferulic acid, Dietary Supplement: Treated bran breadThis is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males
- Age > 18
- 20 < BMI < 30
Key exclusion criteria (6 listed)
- Use of any medication
- Smoking
- Consumption of 3 or more glasses of alcoholic drinks per day
- Donation of more than 500 ml blood (<6 months prior to the start of the study)
- Vegetarian lifestyle (because the standardised meal contains meat)
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 |
|---|---|---|
| ferulic acidAlso: Wholegrain bread, Bran, 4-hydroxy-3-methoxycinnamic acidFerulic acid is naturally contained in wholegrain bread. Bran is the main source of ferulic acid while is low in white flour. Ferulic acid is mainly covalently bound to fiber and low bioaccessible. The bran is pretreated to increase the bioavailability of ferulic acid by increasing the free ferulic acid released from the food matrix. | Other | Control, Treated bran bread |
| Treated bran breadThis is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation | Dietary supplement | Treated bran bread |
| wholegrain breadThe control is the wholegrain bread enriched with bran that has not been pretreated | Dietary supplement | Control |
Primary outcome
Ferulic acid is measured in plasma to determine maximal concentration (Cmax), time-point of Cmax (tmax) and area under the curve (AUC). Ferulic acid is also measured in 24-hour urine sample to determine its excretion.
Time frame: 24 h
1 secondary outcome
Colonic metabolites derived from ferulic acid, short chain fatty acids and antioxidant capacity are measured in plasma to determine their relation with the plasma levels of ferulic acid. Cytokines will be measured in ex vivo LPS stimulated blood.
Time frame: 24 h
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 9 Aug 2018.
Related trials for Healthy Males
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
Healthy Participants
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
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.
Aalt Bast, Professor principal investigator
Universit of Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferulic acid, Treated bran bread and wholegrain bread in people with Healthy Males, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 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 9 Aug 2018. 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 Netherlands. 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?
Ferulic acid is measured in plasma to determine maximal concentration (Cmax), time-point of Cmax (tmax) and area under the curve (AUC). Ferulic acid is also measured in 24-hour urine sample to determine its excretion. (time frame: 24 h). 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 9 Aug 2018.