Research Center for High Performance Sport. Universidad Católica de Murcia
La Ñora, Murcia, 30107, Spain
NCT Number: NCT07341789
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.
Interested in participating?
Request Info18 year–45 year
Male
Interventional
Not applicable
La Ñora, Murcia, 30107, Spain
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
digestive system.
Subjects in this group will intake 1 mg/day of vitamin B12.
Other names: 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).
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
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Francisco Javier Martínez Noguera
Other
Effects of Supplementation With a New Formulation of Vitamin B12, Natural Orange Extract and a Combination of Both on Physical and Mental Performance.
Acronym: MECHEPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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