Vitamin B12 AbsorptionNCT06096298
Bioavailability of Vitamin B12 in Bread Using Fermented Faba Bean as B12 Source in Healthy Volunteers (BeanBread)
A study testing Vitamin B12 bread in people with Vitamin B12 Absorption, run by University of Helsinki.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Absorption
- What is being tested?
- Vitamin B12 bread
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to 22 Dec 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Body mass index between 18.5 and 35 kg/m2
- No exclusion criteria listed below
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Vitamin B12 Absorption
- Being tested
- Vitamin B12 bread, Control bread
- Keywords
- cobalamin, holotranscobalamin, vitamin B12, absorption, propionibacterium freudenreichii, fermented faba bean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12 breadOther
Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria.
Control breadOther
Wheat bread with 30 % of wheat flour replaced with fermented faba bean flour.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B12 bread | Active comparator | 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. Receives: Other: Vitamin B12 bread |
| Positive control | Active comparator | Daily dose of control bread (0 µg of vitamin B12/d and B12 tablet (15 µg of vitamin B12/d) for 2 consecutive days. Receives: Other: Control bread |
| Negative control | Placebo comparator | Daily dose of control bread (0 µg of vitamin B12/d and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days. Receives: Other: Control bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12 bound to transcobalamin II (holoTc)
Changes in serum holotranscobalamin concentrations after intake of vitamin B12
Measured: 2 days
Total B12
Changes in serum total B12 concentrations after intake of vitamin B12
Measured: 2 days
Secondary outcomes (1)
The intensity of gastrointestinal symptoms measured by a visual analogue scale
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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startOct 2023 (estimated)
- Primary completion22 Dec 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B12 AbsorptionStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Maria Pajari, University of Helsinki
- Investigators
- Anne-Maria Pajari, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096298
- Sponsor's protocol ID
- BeanBread-HY
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected is confidential and cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Vitamin B12 in Bread Using Fermented Faba Bean as B12 Source in Healthy Volunteers (BeanBread)
- ClinicalTrials.gov ID
- NCT06096298
- Acronym / sponsor ID
- BeanBread-HY
- Conditions
- Vitamin B12 Absorption
- Keywords
- cobalamin, holotranscobalamin, vitamin B12, absorption, propionibacterium freudenreichii, fermented faba bean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 23 Oct 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin B12 bread | Active comparator | Other: Vitamin B12 breadDaily dose of bread containing B12 (15 µg of vitamin B12/d) and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days. |
| Positive control | Active comparator | Other: Control breadDaily dose of control bread (0 µg of vitamin B12/d and B12 tablet (15 µg of vitamin B12/d) for 2 consecutive days. |
| Negative control | Placebo comparator | Other: Control breadDaily dose of control bread (0 µg of vitamin B12/d and placebo tablet (0 µg of vitamin B12/d) for 2 consecutive days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Body mass index between 18.5 and 35 kg/m2
- No exclusion criteria listed below
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| Vitamin B12 breadWheat bread with 30 % of wheat flour replaced with fermented faba bean flour containing vitamin B12 produced by P. freudenreichii bacteria. | Other | Vitamin B12 bread |
| Control breadWheat bread with 30 % of wheat flour replaced with fermented faba bean flour. | Other | Negative control, Positive control |
Primary outcome
Vitamin B12 bound to transcobalamin II (holoTc)
Time frame: 2 days
Changes in serum holotranscobalamin concentrations after intake of vitamin B12
Total B12
Time frame: 2 days
Changes in serum total B12 concentrations after intake of vitamin B12
1 secondary outcome
The intensity of gastrointestinal symptoms measured by a visual analogue scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No. The data collected is confidential and cannot be shared.
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.
Anne-Maria Pajari, PhD principal investigator
University of Helsinki
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 bread in people with Vitamin B12 Absorption, run by University of Helsinki.
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 3 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Maria Pajari, PhD (+358294158203, anne-maria.pajari@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin B12 bound to transcobalamin II (holoTc) (time frame: 2 days). 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?
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 25 Oct 2023.