Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin B 12, Natural orange extract, Vitamina B12 + natural orange extract, Microcrystalline Cellulose.
- Who it may be relevant to
- Registry conditions: Vitamin b12, Supplementation During Endurance Performance, Flavonoids, Mental Fatigue. Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Dietary supplement Vitamin B 12
Subjects in this group will intake 1 mg/day of vitamin B12. - Dietary supplement Natural orange extract
Subjects in this groups will intake 500 mg/day of natural orange extract. - Combination product 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). - Dietary supplement Microcrystalline Cellulose
Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Primary outcome measures
- Wingate test [Time frame: Throughout study completion, an average of 4 weeks]
Secondary outcome measures (11)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Research Center for High Performance Sport. Universidad Católica de Murcia — La Ñora
Identifiers
NCT: NCT07341789 · CE092504