The Bread Trial: Effects of Bread Fortified With Folic Acid and Vitamin B12

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: consumption of fortified bread

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Wageningen, Netherlands, 6700HD
    • Wageningen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 50-75y

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
serum B12 status
serum folate status

Secondary Outcome Measures

Outcome Measure
erythrocyte folate;
homocysteine;
MMA;
holoTC

Collaborators and Investigators

• Sponsor: Wageningen Centre for Food Sciences
• Investigators: Principal Investigator: Petra Verhoef, PhD, Wageningen University; Principal Investigator: Ingeborg Brouwer, PhD, Wageningen University; Principal Investigator: Martijn Katan, Professor, Wageningen University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: July 17, 2006
• First Submitted That Met QC Criteria: July 17, 2006
• First Posted (Estimate): July 18, 2006

Study Record Updates

• Last Update Posted (Estimate): July 9, 2007
• Last Update Submitted That Met QC Criteria: July 6, 2007
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: no specific conditions
• Other Study ID Numbers: 06/02