Evaluation of the Effect of a New Formulation of Vitamin B12 on Physical and Mental Performance in Trained Cyclists.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Wingate test
研究概览
简要总结
This clinical study evaluates the effect of acute intake of a new vitamin B12 formulation on anaerobic and cognitive performance variables. One of the limiting factors for the potential beneficial effects of vitamin B12 is its bioavailability. This new formula improves this aspect, so that by improving plasma levels of B12 we will be able to relate whether this situation may be related to improved performance or cognitive tasks.
详细描述
Participants
All participants were informed about the procedures and provided signed informed consent. The study was conducted in accordance with the guidelines of the Declaration of Helsinki Declaration for Research Involving Human Subjects and the protocol was approved by the Institutional Review/Ethics Committee of the Catholic University of Murcia (Code: CE052416).
Study design
Randomized, double-blind, placebo-controlled, crossover clinical trial with 2 study groups (vitamin B12 and placebo). Cyclists were instructed to take the supplement (vitamin B12 or placebo) with breakfast on the three days before the tests and 3h before the test day, and to continue with their usual diet and training programme. Subjects in both groups were instructed not to consume vitamin B12-rich foods for 7 days before and during the study. Between each intervention (B12 and Placebo) there was a 7-day washout period.
Procedures
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
- Double (Participant, Investigator)
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
- •Male cyclists who have competed in both junior and amateur categories.
- •Cycling between 6-15 hours of training per week.
- •BMI between 18-25 kg/m2.
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 (B12)
Subjects in this group will intake 1 mg/day of vitamin B12 three days before the tests.
干预措施: Vitamin B12 (B12) (Dietary Supplement)
PLACEBO (PLA)
Subjects in this group will intake 200 mg/day of microcrystalline cellulose three days before the tests.
干预措施: PLACEBO (PLA) (Dietary Supplement)
结局指标
主要结局
Wingate test
时间窗: Throughout study completion, an average of 3 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 3 weeks)
- Biochemical markers(Throughout study completion, an average of 3 weeks)
- Sleep Quality Questionnaire (Pittsburgh)(Throughout study completion, an average of 3 weeks)
研究者
Francisco Javier Martínez Noguera
PhD (Head of the nutrition area of the Research Center for High Performance Sport)
Universidad Católica San Antonio de Murcia