Effects of Supplementation With a New Formulation of Vitamin B12, Natural Orange Extract and a Combination of Both on Physical and Mental Performance.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wingate test
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Vitamin B12
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.
干预措施: Vitamin B 12 (Dietary Supplement)
Natural orange extract
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.
干预措施: Natural orange extract (Dietary Supplement)
Vitamin B12 + natural orange extract
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.
干预措施: Vitamina B12 + natural orange extract (Combination Product)
Placebo
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.
干预措施: Microcrystalline Cellulose (Dietary Supplement)
结局指标
主要结局
Wingate test
时间窗: 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.
次要结局
- Mental fatigue test(Throughout study completion, an average of 4 weeks)
- Hematological Parameters(Throughout study completion, an average of 4 weeks)
- Iron Status Marker(Throughout study completion, an average of 4 weeks)
- Vitamin B12 Status - Serum Vitamin B12(Throughout study completion, an average of 4 weeks)
- Functional Vitamin B12 Biomarkers(Throughout study completion, an average of 4 weeks)
- Muscle Damage Markers(Throughout study completion, an average of 4 weeks)
- Hepatic Enzymes(Throughout study completion, an average of 4 weeks)
- Inflammatory Marker(Throughout study completion, an average of 4 weeks)
- Oxidative Stress Marker(Throughout study completion, an average of 4 weeks)
- Neurotransmitters(Throughout study completion, an average of 4 weeks)
- Neurotrophic Factor(Throughout study completion, an average of 4 weeks)
研究者
Francisco Javier Martínez Noguera
Co-Principal Investigator
Universidad Católica San Antonio de Murcia