Vitamin b12MECHEPSNCT07341789
Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance
A study testing Vitamin B 12, Natural orange extract and Vitamina B12 + natural orange extract in people with Vitamin b12 and Supplementation During Endurance Performance, run by Francisco Javier Martínez Noguera at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin b12, Supplementation During Endurance Performance, Flavonoids
- What is being tested?
- Vitamin B 12, Natural orange extract and Vitamina B12 + natural orange extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Research Center for High Performance Sport. Universidad Católica de Murcia
La Ñora, Murcia, 30107
About this study
Official title: Effects of Supplementation With a New Formulation of Vitamin B12, Natural Orange Extract and a Combination of Both 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.
Read the detailed description
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.
- Conditions
- Vitamin b12, Supplementation During Endurance Performance, Flavonoids, Mental Fatigue, Biomarker Feedback
- Being tested
- Vitamin B 12, Natural orange extract, Vitamina B12 + natural orange extract, Microcrystalline Cellulose
- Keywords
- Ergogenic aids, Wingate test, Vitamin B12, Polyphenols, Performance, Natural orange extract
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B 12Dietary supplement
Also called Vitamin B12
Subjects in this group will intake 1 mg/day of vitamin B12.
Natural orange extractDietary supplement
Subjects in this groups will intake 500 mg/day of natural orange extract.
Vitamina B12 + natural orange extractCombination product
This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day).
Microcrystalline CelluloseDietary supplement
Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B12 | Experimental | This group will take 1.0 mg of vitamin B12 two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. Receives: Dietary Supplement: Vitamin B 12 |
| Natural orange extract | Experimental | This group will take 500 mg of natural orange extract two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. Receives: Dietary Supplement: Natural orange extract |
| Vitamin B12 + natural orange extract | Experimental | This group will take 1.0 mg of vitamin B12 + 500 mg of natural orange extract two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. Receives: Combination Product: Vitamina B12 + natural orange extract |
| Placebo | Placebo comparator | This group will take 500 mg of microcrystalline cellulose two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. Receives: Dietary Supplement: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wingate test
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.
Measured: Throughout study completion, an average of 4 weeks
Secondary outcomes (11)
Mental fatigue test
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.
Measured: Throughout study completion, an average of 4 weeks
Hematological Parameters
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.
Measured: Throughout study completion, an average of 4 weeks
Iron Status Marker
Serum ferritin concentration measured as an indicator of iron status, will be measured from venous blood samples before and after performance tests.
Measured: Throughout study completion, an average of 4 weeks
Vitamin B12 Status - Serum Vitamin B12
Serum vitamin B12 concentration measured from venous blood samples, will be measured from venous blood samples before and after performance tests.
Measured: Throughout study completion, an average of 4 weeks
Functional Vitamin B12 Biomarkers
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.
Measured: Throughout study completion, an average of 4 weeks
Muscle Damage Markers
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.
Measured: Throughout study completion, an average of 4 weeks
Hepatic Enzymes
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.
Measured: Throughout study completion, an average of 4 weeks
Inflammatory Marker
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.
Measured: Throughout study completion, an average of 4 weeks
Oxidative Stress Marker
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.
Measured: Throughout study completion, an average of 4 weeks
Neurotransmitters
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.
Measured: Throughout study completion, an average of 4 weeks
Neurotrophic Factor
Description:
Serum Brain-Derived Neurotrophic Factor (BDNF) concentration, will be measured from venous blood samples before and after performance tests.
Measured: Throughout study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Dec 2025
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin b12Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A triple-blind, randomized, crossover clinical trial will be conducted with three experimental groups (vitamin B12 + natural orange extract; natural orange extract; and vitamin B12) and one placebo group (microcrystalline cellulose). Acute effects will be evaluated after a loading phase (three intakes, one per day including the test day). A 7-day washout period will be implemented between interventions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Javier Martínez Noguera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Javier Martínez Noguera, Universidad Católica San Antonio de Murcia
- Investigators
- Francisco Javier Martinez Noguera, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341789
- Sponsor's protocol ID
- CE092504
- Acronym
- MECHEPS
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supplementation With a New Formulation of Vitamin B12, Natural Orange Extract and a Combination of Both on Physical and Mental Performance.
- ClinicalTrials.gov ID
- NCT07341789
- Acronym / sponsor ID
- MECHEPS / CE092504
- Conditions
- Vitamin b12, Supplementation During Endurance Performance, Flavonoids, Mental Fatigue, Biomarker Feedback
- Keywords
- Ergogenic aids, Wingate test, Vitamin B12, Polyphenols, Performance, Natural orange extract
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Francisco Javier Martínez NogueraUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Jan 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A triple-blind, randomized, crossover clinical trial will be conducted with three experimental groups (vitamin B12 + natural orange extract; natural orange extract; and vitamin B12) and one placebo group (microcrystalline cellulose). Acute effects will be evaluated after a loading phase (three intakes, one per day including the test day). A 7-day washout period will be implemented between interventions.
| Arm | Type | Receives |
|---|---|---|
| Vitamin B12 | Experimental | Dietary Supplement: Vitamin B 12This group will take 1.0 mg of vitamin B12 two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. |
| Natural orange extract | Experimental | Dietary Supplement: Natural orange extractThis group will take 500 mg of natural orange extract two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. |
| Vitamin B12 + natural orange extract | Experimental | Combination Product: Vitamina B12 + natural orange extractThis group will take 1.0 mg of vitamin B12 + 500 mg of natural orange extract two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. |
| Placebo | Placebo comparator | Dietary Supplement: Microcrystalline CelluloseThis group will take 500 mg of microcrystalline cellulose two days before the tests and 3 hours before each test. Therefore, the supplementation will last 3 days in total. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 B 12Also: Vitamin B12Subjects in this group will intake 1 mg/day of vitamin B12. | Dietary supplement | Vitamin B12 |
| Natural orange extractSubjects in this groups will intake 500 mg/day of natural orange extract. | Dietary supplement | Natural orange extract |
| Vitamina B12 + natural orange extractThis group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day). | Combination product | Vitamin B12 + natural orange extract |
| Microcrystalline CelluloseMicrocrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin. | Dietary supplement | Placebo |
Primary outcome
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.
11 secondary outcomes
Mental fatigue test
Time frame: Throughout study completion, an average of 4 weeks
Hematological Parameters
Time frame: Throughout study completion, an average of 4 weeks
Iron Status Marker
Time frame: Throughout study completion, an average of 4 weeks
Vitamin B12 Status - Serum Vitamin B12
Time frame: Throughout study completion, an average of 4 weeks
Functional Vitamin B12 Biomarkers
Time frame: Throughout study completion, an average of 4 weeks
Muscle Damage Markers
Time frame: Throughout study completion, an average of 4 weeks
Hepatic Enzymes
Time frame: Throughout study completion, an average of 4 weeks
Inflammatory Marker
Time frame: Throughout study completion, an average of 4 weeks
Oxidative Stress Marker
Time frame: Throughout study completion, an average of 4 weeks
Neurotransmitters
Time frame: Throughout study completion, an average of 4 weeks
Neurotrophic Factor
Time frame: Throughout study completion, an average of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Francisco Javier Martinez Noguera, PhD principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B 12, Natural orange extract and Vitamina B12 + natural orange extract in people with Vitamin b12 and Supplementation During Endurance Performance, run by Francisco Javier Martínez Noguera at 1 site in Spain.
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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wingate test (time frame: Throughout study completion, an average of 4 weeks). 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 14 Jan 2026.