Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Vitamin B 12, Natural orange extract, Vitamina B12 + natural orange extract, Microcrystalline Cellulose.
- Кому может быть актуально
- Состояния в реестре: Vitamin b12, Supplementation During Endurance Performance, Flavonoids, Mental Fatigue. Базовые параметры: 18 лет — 45 лет · Мужчины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of Supplementation With a New Formulation of Vitamin B12, Natural Orange Extract and a Combination of Both on Physical and Mental Performance.
Обзор
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.
Подробное описание
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.
Вмешательства
- Пищевая добавка Vitamin B 12
Subjects in this group will intake 1 mg/day of vitamin B12. - Пищевая добавка Natural orange extract
Subjects in this groups will intake 500 mg/day of natural orange extract. - Комбинированный продукт 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). - Пищевая добавка Microcrystalline Cellulose
Microcrystalline cellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Первичные конечные точки
- Wingate test [Срок оценки: Throughout study completion, an average of 4 weeks]
Вторичные конечные точки (11)
- Mental fatigue test [Срок оценки: Throughout study completion, an average of 4 weeks]
- Hematological Parameters [Срок оценки: Throughout study completion, an average of 4 weeks]
- Iron Status Marker [Срок оценки: Throughout study completion, an average of 4 weeks]
- Vitamin B12 Status - Serum Vitamin B12 [Срок оценки: Throughout study completion, an average of 4 weeks]
- Functional Vitamin B12 Biomarkers [Срок оценки: Throughout study completion, an average of 4 weeks]
- Muscle Damage Markers [Срок оценки: Throughout study completion, an average of 4 weeks]
- Hepatic Enzymes [Срок оценки: Throughout study completion, an average of 4 weeks]
- Inflammatory Marker [Срок оценки: Throughout study completion, an average of 4 weeks]
- Oxidative Stress Marker [Срок оценки: Throughout study completion, an average of 4 weeks]
- Neurotransmitters [Срок оценки: Throughout study completion, an average of 4 weeks]
- Neurotrophic Factor [Срок оценки: Throughout study completion, an average of 4 weeks]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- Research Center for High Performance Sport. Universidad Católica de Murcia — La Ñora
Идентификаторы
NCT: NCT07341789 · CE092504