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NCT Number: NCT07341789

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Research Center for High Performance Sport. Universidad Católica de Murcia

La Ñora, Murcia, 30107, Spain

About this study

A triple-blind, randomized, crossover clinical trial will be conducted with three experimental phases (vitamin B12 + natural orange extract, natural orange extract, vitamin B12) and one control phase (placebo), including evaluations of the acute effect after a loading phase (three intakes, one per day including the test day).

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).

Tests

  • General health analysis: A general blood test (including standard biochemistry and complete blood count) will be performed during the recruitment phase.
  • Medical examination: A cardiorespiratory assessment at rest will be conducted to rule out any underlying pathology.
  • Specific performance-related blood analysis: Conducted at four time points (total of eight measurements): baseline during recruitment, pre- and post-test in each condition (supplement / placebo). Parameters will include: complete blood count, ferritin, CK, LDH, vitamin B12, transaminases, reticulocytes, homocysteine, C-reactive protein, IL-6, methylmalonic acid, holo-transcobalamin II, 8-OHdG (8-hydroxy-2'-deoxyguanosine), dopamine, serotonin, and Brain-Derived Neurotrophic Factor (BDNF).
  • Anthropometry: Determination of body composition parameters to characterize the sample.
  • Wingate test: Conducted using the standard load protocol, consisting of five maximal 30-second sprints with 3-minute recovery intervals between repetitions.
  • Mental fatigue test using light-based reaction tasks: The time required to complete a light reaction sequence will be measured before and after the fatigue protocol.
  • Genetic test: A saliva sample will be collected to analyze genetic profiles related to food intolerances and vitamin absorption. The objective is to identify potential explanations for interindividual differences in absorption capacity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Smokers or regular alcohol drinkers.
  • Persons suffering from a metabolic, cardiorespiratory or digestive pathology or anomaly.

digestive system.

  • People who have suffered an injury in the last 6 months that limits the performance of the study tests. of the study tests.
  • People taking supplements or medication in the 2 weeks before the start of the study.

Treatment and study plan

Vitamin B 12

Dietary Supplement

Subjects in this group will intake 1 mg/day of vitamin B12.

Other names: Vitamin B12

Natural orange extract

Dietary Supplement

Subjects in this groups will intake 500 mg/day of natural orange extract.

Vitamina B12 + natural orange extract

Combination Product

This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day).

microcrystalline cellulose

Dietary Supplement

Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.

Primary outcomes

  1. Wingate test

    Time frame: Throughout study completion, an average of 4 weeks

    This test consists of 5 efforts of 30 seconds at maximum intensity with a recovery of 3 minutes on a bike. In this test the peak and average power of each effort and the total average will be evaluated. In addition, the time to maximum peak power and the fatigue index.

Secondary outcomes

  1. Mental fatigue test

    Time frame: Throughout study completion, an average of 4 weeks

    In this test, we will measure the speed of reaction in the resolution of a sequence of lights set by the researcher before and after the end of the performance test.

  2. Hematological Parameters

    Time frame: Throughout study completion, an average of 4 weeks

    A complete blood count (including red blood cell count, hemoglobin, hematocrit, and white blood cell count) will be measured from venous blood samples before and after performance tests.

  3. Iron Status Marker

    Time frame: Throughout study completion, an average of 4 weeks

    Serum ferritin concentration measured as an indicator of iron status, will be measured from venous blood samples before and after performance tests.

  4. Vitamin B12 Status - Serum Vitamin B12

    Time frame: Throughout study completion, an average of 4 weeks

    Serum vitamin B12 concentration measured from venous blood samples, will be measured from venous blood samples before and after performance tests.

  5. Functional Vitamin B12 Biomarkers

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Plasma methylmalonic acid, holo-transcobalamin II, and homocysteine concentrations assessed as functional biomarkers of vitamin B12 status, will be measured from venous blood samples before and after performance tests.

  6. Muscle Damage Markers

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Serum creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations measured as indicators of exercise-induced muscle damage, will be measured from venous blood samples before and after performance tests.

  7. Hepatic Enzymes

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Serum glutamic-oxaloacetic transaminase (GOT/AST) and glutamic-pyruvic transaminase (GPT/ALT) concentrations, will be measured from venous blood samples before and after performance tests.

  8. Inflammatory Marker

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Serum C-reactive protein (CRP) concentration measured as a marker of systemic inflammation, will be measured from venous blood samples before and after performance tests.

  9. Oxidative Stress Marker

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Plasma 8-hydroxy-2-deoxyguanosine (8-OHdG) concentration measured as a marker of oxidative DNA damage, will be measured from venous blood samples before and after performance tests.

  10. Neurotransmitters

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Plasma serotonin, dopamine, norepinephrine, and epinephrine concentrations measured as indicators of neuroendocrine response, will be measured from venous blood samples before and after performance tests.

  11. Neurotrophic Factor

    Time frame: Throughout study completion, an average of 4 weeks

    Description:

    Serum Brain-Derived Neurotrophic Factor (BDNF) concentration, will be measured from venous blood samples before and after performance tests.

Sponsors and collaborators

Lead sponsor

Francisco Javier Martínez Noguera

Other

Registry information

Official study title

Effects of Supplementation With a New Formulation of Vitamin B12, Natural Orange Extract and a Combination of Both on Physical and Mental Performance.

Acronym: MECHEPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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