Effect of a New Formulation of Vitamin B12 on Physical and Mental

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

This clinical study evaluates the effect of acute intake of a new vitamin B12 formulation on anaerobic and cognitive performance variables.

It had two arms (groups): Vitamin B12 (B12) (experimental) and PLACEBO (PLA) (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Participants All participants were informed about the procedures and provided signed informed consent.

Study design Randomized, double-blind, placebo-controlled, crossover clinical trial with 2 study groups (vitamin B12 and placebo).

Cyclists were instructed to take the supplement (vitamin B12 or placebo) with breakfast on the three days before the tests and 3h before the test day, and to continue with their usual diet and training programme.

Subjects in both groups were instructed not to consume vitamin B12-rich foods for 7 days before and during the study.

Who Took Part

The registry lists 18 planned participants were the target.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Male cyclists who have competed in both junior and amateur categories. Cycling between 6-15 hours of training per week. BMI between 18-25 kg/m2.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: smokers or regular alcohol drinkers; persons suffering from a metabolic, cardiorespiratory or digestive pathology or anomaly; people who have suffered an injury in the last 6 months that limits the performance of the study tests. of the study tests.

How the Study Was Run

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

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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 2024-07-01 with completion listed for 2024-11-30.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Wingate test (time frame: Throughout study completion, an average of 3 weeks).

It also tracked 3 secondary outcomes, for example Mental fatigue test, Biochemical markers and Sleep Quality Questionnaire (Pittsburgh).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 18 people.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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