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Trial record 89 of 732 for:    Area Under Curve AND Bioavailability

Increasing Ferulic Acid Bioavailability in Bran

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777543
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE October 16, 2008
First Posted Date  ICMJE October 22, 2008
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00777543 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Ferulic Acid Bioavailability in Bran
Official Title  ICMJE The Effect of Pre-treatment of Bran on the Bioavailability of Ferulic Acid and Other Bioactive Compounds From Wholegrain Breads Enriched in Bran
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy Males
Intervention  ICMJE
  • Other: ferulic 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.
    Other Names:
    • Wholegrain bread
    • Bran
    • 4-hydroxy-3-methoxycinnamic acid
  • Dietary Supplement: Treated bran bread
    This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation
  • Dietary Supplement: wholegrain bread
    The control is the wholegrain bread enriched with bran that has not been pretreated
Study Arms  ICMJE
  • Control
    The control is the wholegrain bread enriched with bran that has not been pretreated.
    Interventions:
    • Other: ferulic acid
    • Dietary Supplement: wholegrain bread
  • Experimental: Treated bran bread
    This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation
    Interventions:
    • Other: ferulic acid
    • Dietary Supplement: Treated bran bread
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2008)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males
  • Age > 18
  • 20 < BMI < 30

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777543
Other Study ID Numbers  ICMJE 08-3-079
NL26116.068.08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aalt Bast, Professor Universit of Maastricht
PRS Account Maastricht University Medical Center
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP