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

NCT06096298 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-10-25

No results posted yet for this study

Summary

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.

Conditions

  • Vitamin B12 Absorption

Interventions

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.

OTHER

Control bread

Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour.

Sponsors & Collaborators

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Anne-Maria Pajari, PhD · University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-12-22
Completion
2023-12-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096298 on ClinicalTrials.gov