NCT00777543

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 9, 2018

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

October 16, 2008

Last Update Submit

August 7, 2018

Conditions

Keywords

BioavailabilityFerulic acidPhenolic compoundsColonic metabolitesImmunomodulatory effectsNo disease

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

OTHER

The control is the wholegrain bread enriched with bran that has not been pretreated.

Other: ferulic acidDietary 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

Other: ferulic acidDietary Supplement: Treated bran bread

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.

Also known as: Wholegrain bread, Bran, 4-hydroxy-3-methoxycinnamic acid
ControlTreated bran bread
Treated bran breadDIETARY_SUPPLEMENT

This is a wholegrain bread enriched with bran that has been pretreated with food-grade enzymes and yeast fermentation

Treated bran bread
wholegrain breadDIETARY_SUPPLEMENT

The control is the wholegrain bread enriched with bran that has not been pretreated

Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

ferulic acid

Study Officials

  • Aalt Bast, Professor

    Universit of Maastricht

    PRINCIPAL INVESTIGATOR

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

Locations