Increasing Ferulic Acid Bioavailability in Bran
The Effect of Pre-treatment of Bran on the Bioavailability of Ferulic Acid and Other Bioactive Compounds From Wholegrain Breads Enriched in Bran
2 other identifiers
interventional
8
1 country
1
Brief 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 acid and short chain fatty acids (SCFA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 9, 2018
November 1, 2009
1 year
October 16, 2008
August 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
24 h
Study Arms (2)
Control
OTHERThe control is the wholegrain bread enriched with bran that has not been pretreated.
Treated bran bread
EXPERIMENTALThis is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation
Interventions
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.
This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation
The control is the wholegrain bread enriched with bran that has not been pretreated
Eligibility Criteria
You may qualify if:
- Healthy males
- Age \> 18
- \< BMI \< 30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maastricht
Maastricht, 6200 MD, Netherlands
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Aalt Bast, Professor
Universit of Maastricht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 22, 2008
Study Start
November 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
August 9, 2018
Record last verified: 2009-11