Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance
NCT ID: NCT07341789
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
20 participants
INTERVENTIONAL
2025-12-01
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Vitamin B12
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.
Vitamin B 12
Subjects in this group will intake 1 mg/day of vitamin B12.
Natural orange extract
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.
Natural orange extract
Subjects in this groups will intake 500 mg/day of natural orange extract.
Vitamin B12 + natural orange extract
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.
Vitamina B12 + natural orange extract
This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day).
Placebo
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.
Microcrystalline Cellulose
Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Interventions
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Vitamin B 12
Subjects in this group will intake 1 mg/day of vitamin B12.
Natural orange extract
Subjects in this groups will intake 500 mg/day of natural orange extract.
Vitamina B12 + natural orange extract
This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day).
Microcrystalline Cellulose
Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Francisco Javier Martínez Noguera
OTHER
Responsible Party
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Francisco Javier Martínez Noguera
Co-Principal Investigator
Principal Investigators
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Francisco Javier Martinez Noguera, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica San Antonio de Murcia
Locations
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Research Center for High Performance Sport. Universidad Católica de Murcia
La Ñora, Murcia, Spain
Countries
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Other Identifiers
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CE092504
Identifier Type: -
Identifier Source: org_study_id
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