Biomarker Feedback, Flavonoids, Mental Fatigue, Supplementation During Endurance Performance, Vitamin b12
Conditions
Keywords
Ergogenic aids, Wingate test, Vitamin B12, Polyphenols, Performance, Natural orange extract
Brief 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.
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_SUPPLEMENTVitamin B 12
Subjects in this group will intake 1 mg/day of vitamin B12.
DIETARY_SUPPLEMENTNatural orange extract
Subjects in this groups will intake 500 mg/day of natural orange extract.
COMBINATION_PRODUCTVitamina 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_SUPPLEMENTMicrocrystalline Cellulose
Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Sponsors
Francisco Javier Martínez Noguera
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The company that formulated the supplements and placebo carried out the randomization, so no one on the research team or among the sponsors knew which group each study subject belonged to. The results of the randomization were sent to our laboratory after the study was completed to determine which subjects were in each group.
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wingate test | 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
| Measure | Time frame | Description |
|---|---|---|
| Hematological Parameters | 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. |
| Iron Status Marker | 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. |
| Vitamin B12 Status - Serum Vitamin B12 | 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. |
| Functional Vitamin B12 Biomarkers | 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. |
| Muscle Damage Markers | 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. |
| Mental fatigue test | 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. |
| Inflammatory Marker | 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. |
| Oxidative Stress Marker | 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. |
| Neurotransmitters | 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. |
| Neurotrophic Factor | 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. |
| Hepatic Enzymes | 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. |
Countries
Spain
Outcome results
None listed