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

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12).

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.

It had three arms (groups): Vitamin B12 bread (active comparator), Positive control (active comparator) and Negative control (placebo comparator).

The registry classes the interventions as other.

More on the Plan

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.

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).

Who Took Part

25 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index between 18.5 and 35 kg/m2.

The full record lists 3 inclusion and 20 exclusion criteria; among the exclusions: food allergies against ingredients in foods supplemented in the study; pregnancy and/or breastfeeding; regular use of food supplements containg b12.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cyanocobalamin (Vitamin B12) and the comparison in turn, acting as their own control.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-10 with completion listed for 2023-12-22.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Vitamin B12 bound to transcobalamin II (holoTc) (time frame: 2 days). Total B12 (time frame: 2 days).

It also tracked 1 secondary outcome, for example The intensity of gastrointestinal symptoms measured by a visual analogue scale.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 25 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.