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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06096298
Enrollment
25
Registered
2023-10-23
Start date
2023-10-31
Completion date
2023-12-22
Last updated
2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin B12 Absorption

Keywords

cobalamin, holotranscobalamin, vitamin B12, absorption, propionibacterium freudenreichii, fermented faba bean

Brief 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.

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.

Interventions

OTHERVitamin B12 bread

Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria.

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

Sponsors

University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

The study is double-masked - neither the researchers or the participants know which bread they are eating.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Body mass index between 18.5 and 35 kg/m2 * No

Exclusion criteria

listed below

Design outcomes

Primary

MeasureTime frameDescription
Vitamin B12 bound to transcobalamin II (holoTc)2 daysChanges in serum holotranscobalamin concentrations after intake of vitamin B12
Total B122 daysChanges in serum total B12 concentrations after intake of vitamin B12

Secondary

MeasureTime frameDescription
The intensity of gastrointestinal symptoms measured by a visual analogue scale4 weeksStudy 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)

Contacts

Primary ContactAnne-Maria Pajari, PhD
anne-maria.pajari@helsinki.fi+358294158203
Backup ContactMaj Lundberg, MSc
maj.lundberg@helsinki.fi+358504315431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026