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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:
Tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B 12 | Dietary Supplement | Subjects in this group will intake 1 mg/day of vitamin B12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout study completion, an average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout study completion, an average of 4 weeks |
| Hematological Parameters |
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Inclusion Criteria:
Exclusion Criteria:
digestive system.
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Javier Martinez Noguera, PhD | Universidad Católica San Antonio de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center for High Performance Sport. Universidad Católica de Murcia | La Ñora | Murcia | 30107 | Spain |
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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.
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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.
| Natural orange extract | Dietary Supplement | Subjects in this groups will intake 500 mg/day of natural orange extract. |
|
| Vitamina B12 + natural orange extract | Combination Product | This group will take the combination of vitamin B12 and Vitamina B12 (1 mg/day) + natural orange extract (500 mg/day). |
|
| Microcrystalline Cellulose | Dietary Supplement | Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Throughout study completion, an average of 4 weeks |
| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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