Effect of Vitamin D and Branched-chain Amino Acids on Physical Performance and Biomarkers of Muscle Fatigue in Runners: an 8-week Randomized, Double-blind
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes in lactate levels compared to the placebo group
研究概览
简要总结
Muscle fatigue caused by physical training is understood as a condition related to the inability to maintain action potential, derived from the alteration in skeletal muscle homeostasis. In long-distance recreational runners, prolonged physical work is performed while maintaining the level of intensity, where a level of fatigue intervenes, which overlaps and generates tiredness to execute the movement continuously. In the last 10 years, sports supplementation has been explored as an aid to increase physical performance, improve muscle recovery and prevent sports injuries.
详细描述
Objective
To analyze the effects of an 8-week training program (TP) with vitamin D and branched-chain amino acids (BCAA) supplementation on physical performance and biomarkers of muscle fatigue in long-distance recreational runners.
Materials and methods
An 8-week randomized controlled clinical trial. Participants will be 64 men aged 25 to 44 years, distributed into 4 intervention groups. Group A: Training + BCAA + Vitamin D. Group B: Training + BCAA + Placebo. Group C: Training + Vitamin D + Placebo. Group D: Training + Placebo + Placebo. Biomarkers of muscle fatigue Interleukin 6 (L-6), Creatine Kinase (CK), Lactate (Lact), Testosterone and Cortisol ratio and serum vitamin D (25(OH)D) and physical performance will be assessed by estimating Maximal oxygen consumption (VO2max) and (Maximal aerobic speed) MAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
The research is categorized as double-blind parallel groups, the study subjects will be blinded, by not recognizing that they are under supplementation and secondly the principal investigator will also be unaware of the assigned treatment.
入排标准
- 年龄范围
- 25 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adults aged 25 to 44
- •Agree to participate in the study
- •Sign a consent form
- •Experience in long-distance running
排除标准
- •Have a previous diagnosis of liver disease, asthma, hypertension, diabetes, cancer, anemia
- •Have a previous diagnosis of a neurological disorder (Alzheimer's disease, Parkinson's disease, epilepsy)
- •Have a musculoskeletal disability
- •Be on medication or supplementation
- •Hypervitaminosis D (>100 ng/mL)
- •Be on a structured training program
- •Use anabolic steroids
研究组 & 干预措施
Group 1 (TP + BCAA + VitD)
Training Program + Branched-Chain Amino Acids + Vitamin D
干预措施: Training program (Other)
Group 1 (TP + BCAA + VitD)
Training Program + Branched-Chain Amino Acids + Vitamin D
干预措施: Branched-Chain Amino Acids (Dietary Supplement)
Group 1 (TP + BCAA + VitD)
Training Program + Branched-Chain Amino Acids + Vitamin D
干预措施: Vitamin D (Dietary Supplement)
Group 2 (TP + BCAA + P2)
Training Program + Branched-Chain Amino Acids + Placebo 2
干预措施: Training program (Other)
Group 2 (TP + BCAA + P2)
Training Program + Branched-Chain Amino Acids + Placebo 2
干预措施: Branched-Chain Amino Acids (Dietary Supplement)
Group 2 (TP + BCAA + P2)
Training Program + Branched-Chain Amino Acids + Placebo 2
干预措施: Placebo 2 (Other)
Group 3 (TP + VitD + P1)
Training Program + Vitamin D (1000 IU) + Placebo 1
干预措施: Training program (Other)
Group 3 (TP + VitD + P1)
Training Program + Vitamin D (1000 IU) + Placebo 1
干预措施: Vitamin D (Dietary Supplement)
Group 3 (TP + VitD + P1)
Training Program + Vitamin D (1000 IU) + Placebo 1
干预措施: Placebo 1 (Other)
Group 4 (TP + P1+ P2)
Training Program + Placebo1 + Placebo 2
干预措施: Training program (Other)
Group 4 (TP + P1+ P2)
Training Program + Placebo1 + Placebo 2
干预措施: Placebo 1 (Other)
Group 4 (TP + P1+ P2)
Training Program + Placebo1 + Placebo 2
干预措施: Placebo 2 (Other)
结局指标
主要结局
Changes in lactate levels compared to the placebo group
时间窗: 8 weeks
mMol/L
Changes in testosterone cortisol ratio compared to the placebo group
时间窗: 8 weeks
mcg/dL
Changes in interleukin-6 levels compared to the placebo group
时间窗: 8 weeks
pg/ml
Changes in cratine kinase levels compared to the placebo group
时间窗: 8 weeks
U/L
Changes in maximal oxygen consumption compared to the placebo group
时间窗: 8 weeks
ml.O2.kg/min
Changes in maximal aerobic speed compared to the placebo group
时间窗: 8 weeks
km/h
次要结局
未报告次要终点
研究者
Pedro Julian Flores Moreno
Doctor of Medical Sciences
Universidad de Colima