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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Subjects in this group will intake 1 mg/day of vitamin B12.
Subjects in this groups will intake 500 mg/day of natural orange extract.
This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day).
Research Center for High Performance Sport. Universidad Católica de Murcia
La Ñora, Murcia, Spain
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.
Time frame: Throughout study completion, an average of 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout study completion, an average of 4 weeks