HealthyNCT00353353
The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12
A study testing consumption of fortified bread in people with Healthy, run by Wageningen Centre for Food Sciences at 1 site in Netherlands.
Trial summary
In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- consumption of fortified bread
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2006to Dec 2006
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 50-75y
Who cannot join
- consumption of < 3 slices of bread/day
- use of B-vitamins in the period three months prior to the study
- treatment with B12-injections in the last 5y
- illness or use of medication interfering with folate or vitamin B12 metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.
Read the detailed description
During a 12 week period subjects will consume
- bread fortified with folic acid and vitamin B12 or
- placebo bread (not fortified)
Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices.
We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.
- Conditions
- Healthy
- Being tested
- consumption of fortified bread
- Keywords
- no specific conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consumption of fortified breadProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
serum B12 status
serum folate status
Secondary outcomes (4)
erythrocyte folate;
homocysteine;
MMA;
holoTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startJul 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen Centre for Food Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Petra Verhoef, PhD, Principal investigator, Wageningen UniversityIngeborg Brouwer, PhD, Principal investigator, Wageningen UniversityMartijn Katan, Professor, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353353
- Sponsor's protocol ID
- 06/02
- Status last verified
- Jul 2007
- First submitted
- 17 Jul 2006
- Last updated
- 9 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Winkels RM, Brouwer IA, Clarke R, Katan MB, Verhoef P. Bread cofortified with folic acid and vitamin B-12 improves the folate and vitamin B-12 status of healthy older people: a randomized controlled trial. Am J Clin Nutr. 2008 Aug;88(2):348-55. doi: 10.1093/ajcn/88.2.348.
PubMed 18689370
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bread Trial: a Demonstration Trial to Show Effects of Fortification of Food With Both Folic Acid and Vitamin B12
- ClinicalTrials.gov ID
- NCT00353353
- Acronym / sponsor ID
- 06/02
- Conditions
- Healthy
- Keywords
- no specific conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wageningen Centre for Food SciencesUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Jul 2006 (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.
In the Netherlands fortification of food products is not yet mandatory. One of the major arguments of the Dutch Health Council to advise against mandatory fortification is the possibility of masking of a vitamin B12 deficiency. A possible solution to overcome the possibility of masking is: fortification of foods with both folic acid and vitamin B12. In this study we want to assess the effects of this fortification strategy on markers of folate and vitamin B12 status.
Detailed description
During a 12 week period subjects will consume
- bread fortified with folic acid and vitamin B12 or
- placebo bread (not fortified)
Bread consumption has to be at least 3 slices per day, fortification level is 100mcg folic acid and 6mcg vitamin B12 per 3 slices.
We will study the effect of this fortification strategy on markers of folate and vitamin B12 status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 50-75y
Key exclusion criteria (4 listed)
- consumption of < 3 slices of bread/day
- use of B-vitamins in the period three months prior to the study
- treatment with B12-injections in the last 5y
- illness or use of medication interfering with folate or vitamin B12 metabolism
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 |
|---|---|---|
| consumption of fortified bread | Procedure or surgery | – |
Primary outcome
serum B12 status
serum folate status
4 secondary outcomes
erythrocyte folate;
homocysteine;
MMA;
holoTC
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 Jul 2007.
- Derived from this study: PubMed 18689370Winkels RM, Brouwer IA, Clarke R, Katan MB, Verhoef P. Bread cofortified with folic acid and vitamin B-12 improves the folate and vitamin B-12 status of healthy older people: a randomized controlled trial. Am J Clin Nutr. 2008 Aug;88(2):348-55. doi: 10.1093/ajcn/88.2.348.
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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.
Petra Verhoef, PhD principal investigator
Wageningen University
Ingeborg Brouwer, PhD principal investigator
Wageningen University
Martijn Katan, Professor principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consumption of fortified bread in people with Healthy, run by Wageningen Centre for Food Sciences 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 1 inclusion and 4 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 Jul 2007. 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?
serum B12 status. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353353, which also lists 1 linked publication.
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 Jul 2007.