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Набор по приглашению NCT07341789

Effects of Vitamin B12 and Natural Orange Extract, and Their Combination on Physical and Mental Performance

Без фазы С лечением Vitamin b12 Supplementation During Endurance Performance Flavonoids Mental Fatigue

Ориентир для пациента и семьи

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 →
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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗