Bioavailability of Vitamin B12 in Bread Using Fermented Faba Bean as B12 Source in Healthy Volunteers (BeanBread)

October 23, 2023 updated by: Anne-Maria Pajari, University of Helsinki
Vitamin B12 is naturally present in animal products, but it could be added to plant-based products through fermentation using the Propionibacterium freudenreichii bacterium. This study aims to investigate the absorption of vitamin B12 synthesized by Propionibacterium freudenreichii from products made with fermented faba bean. The study products are wheat breads of which 30 % of the dry weight has been replaced with fermented faba bean flour. One of the study breads contains vitamin B12 produced by P. freudenreichii bacteria, and the other bread (control bread) is fermented using L. brevis bacteria (does not produce vitamin B12). The participants will eat the study bread for two consecutive days during the study weeks, with a washout period of 12 days. Fasting blood samples are collected on day 1 before administration of the first dose of vitamin B12 and on day 3. Nutrient intake and food consumption will be analyzed from 3-day food records at the baseline and on the bread eating days. The study is carried out in a double-blinded crossover setting.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A human intervention study with healthy volunteers will be carried out to investigate the absorption of vitamin B12 synthesized by Propionibacterium freudenreichii from bread made with fermented faba bean. The study is conducted on healthy, 18-50-year-old volunteers. The study is carried out in a randomized, double-blinded, placebo-controlled crossover design.

The study products are wheat breads of which 30% of the dry weight has been replaced with fermented faba bean flour. One of the study breads contains fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria, and the other bread (control bread) contains faba bean flour fermented with L. brevis bacteria (does not produce vitamin B12). In addition to the study breads, the study participants are given a vitamin supplement containing cyanocobalamin as a positive control during one study week and a placebo supplement as a negative control for two weeks. During each study period, the subjects eat study breads and supplements for two consecutive days, three times a day. The study participants are otherwise allowed to follow their usual diet. On the morning of the first and third study day of each study period, a blood sample is taken from the subjects, from which the vitamin B12 bound to holotranscobalamin II and the total vitamin B12 concentration in the serum are determined. At the baseline of the study, the blood samples are also analyzed for folate, methylmalonate, homocysteine and creatinine concentrations.

Nutrient intake and food consumption will be analyzed from 3-day food records during the run-in week and each study week (total 9 days). The participants will report their gastrointestinal symptoms during the study periods.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy
  • Body mass index between 18.5 and 35 kg/m2
  • No exclusion criteria listed below

Exclusion Criteria:

  • Food allergies against ingredients in foods supplemented in the study
  • pregnancy and/or breastfeeding
  • Regular use of food supplements containg B12
  • Blood donation within 3 months
  • Alcohol consumption more than 24 measures per week
  • Smoking, using snuff
  • Iron, B12 or folate deficiency
  • Anemia
  • small intestinal bacterial overgrowth (SIBO)
  • Gastritis
  • Helicobacter pylori infection
  • Acid reflux
  • Chron's disease
  • Celiac disease
  • Pancreatitis
  • Abdominal surgery
  • Eating disorder
  • Use of supplements containing vitamin B12 in the last year
  • Vitamin B12 injection treatment in the last year
  • Use of metformin, protein pump inhibitors or H2-receptor blockers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin B12 bread
Daily dose of bread containing B12 (15 µg of vitamin B12/d) and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days.
Other: Vitamin B12 bread
Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria.
Active Comparator: Positive control
Daily dose of control bread (0 µg of vitamin B12/d and B12 tablet (15 µg of vitamin B12/d) for 2 consecutive days.
Other: Control bread
Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour.
Placebo Comparator: Negative control
Daily dose of control bread (0 µg of vitamin B12/d and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days.
Other: Control bread
Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin B12 bound to transcobalamin II (holoTc)
Time Frame: 2 days
Changes in serum holotranscobalamin concentrations after intake of vitamin B12
2 days
Total B12
Time Frame: 2 days
Changes in serum total B12 concentrations after intake of vitamin B12
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of gastrointestinal symptoms measured by a visual analogue scale
Time Frame: 4 weeks
Study participants report the intensity of experienced stomach pain, cramps, bloating, flatulence, stomach noise, nausea, heartburn, unpleasant feeling and sudden need to defecate on a scale of zero (no pain at all) to 100 (very intense pain)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Investigators

  • Principal Investigator: Anne-Maria Pajari, PhD, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 22, 2023

Study Completion (Estimated)

December 22, 2023

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeanBread-HY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data collected is confidential and cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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