Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance

What Was Tested

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

The aim of this study was to determine the effects of a new formulation of vitamin B12, natural orange extract, and their combination on physical and mental performance.

It had four arms (groups): Vitamin B12 (experimental), Natural orange extract (experimental), Vitamin B12 + natural orange extract (experimental) and Placebo (placebo comparator).

The registry classes the interventions as combination product and dietary supplement.

More on the Plan

Participants The sample will consist of 20 well-trained male cyclists (road, MTB, or triathlon), training 3-6 sessions per week, aged between 18 and 45 years.

The inclusion criteria will be: * Healthy male (to be certified through medical examination and health analysis). * Aged 18-45 years. * Well-trained (3-6 training sessions per week). * Habitual consumer of citrus fruits (orange, mandarin, lemon, or grapefruit, either whole or as juice).

The objective is to identify potential explanations for interindividual differences in absorption capacity.

Who Took Part

Enrollment: 20 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: Healthy male (to be certified through medical examination and health analysis). Aged 18-45 years. Well-trained (3-6 training sessions per week). Habitual consumer of citrus fruits (orange, mandarin, lemon, or grapefruit, either fresh or juiced).

The full record lists 4 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

It was run as a randomized, crossover and triple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2025-12-01 with completion listed for 2026-04.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Wingate test (time frame: Throughout study completion, an average of 4 weeks).

It also tracked 11 secondary outcomes, for example Mental fatigue test, Hematological Parameters, Iron Status Marker, Vitamin B12 Status - Serum Vitamin B12, Functional Vitamin B12 Biomarkers and Muscle Damage Markers.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 20 people.

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

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

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