Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm
研究概览
简要总结
Operational conditions amplify soldier's constraints and stress factors, upsetting individual and collective adaptive landmarks. The soldier's resistance is strained by the high intensity of stressors, by the long duration of exposure and by their cumulative effect.
This may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint.
The investigators believe that operational strain could manifest itself by a kind of accelerated aging of the organism due to the increased allostatic load without sufficient resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation, etc.).
This aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The pharmacist, carrying out the packaging and labelling of the treatment units, will ensure the blinding. Neither the participant nor the investigator will know what treatment is being administered.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •From 18 to 65 years of age
排除标准
- •Tyrosine intake within the previous 15 days
- •History of neurological or psychiatric disorder
- •History of nephrological or endocrine disorder or liver failure
- •Hereditary tyrosinemia
研究组 & 干预措施
Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
干预措施: Blood collection (Biological)
Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
干预措施: L-Tyrosine 500 Mg (Drug)
Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
干预措施: Psychological questionnaires (Behavioral)
Tyrosine - External Operation
1-month L-Tyrosine treatment following 4-month external operation
干预措施: Photoplethysmography (Device)
Placebo - External Operation
1-month Placebo treatment following 4-month external operation
干预措施: Blood collection (Biological)
Placebo - External Operation
1-month Placebo treatment following 4-month external operation
干预措施: Psychological questionnaires (Behavioral)
Placebo - External Operation
1-month Placebo treatment following 4-month external operation
干预措施: Photoplethysmography (Device)
Placebo - External Operation
1-month Placebo treatment following 4-month external operation
干预措施: Placebo (Drug)
Tyrosine - Rear Base
1-month L-Tyrosine treatment following 4 months at rear base
干预措施: Blood collection (Biological)
Tyrosine - Rear Base
1-month L-Tyrosine treatment following 4 months at rear base
干预措施: L-Tyrosine 500 Mg (Drug)
Tyrosine - Rear Base
1-month L-Tyrosine treatment following 4 months at rear base
干预措施: Psychological questionnaires (Behavioral)
Tyrosine - Rear Base
1-month L-Tyrosine treatment following 4 months at rear base
干预措施: Photoplethysmography (Device)
Placebo - Rear Base
1-month Placebo treatment following 4 months at rear base
干预措施: Blood collection (Biological)
Placebo - Rear Base
1-month Placebo treatment following 4 months at rear base
干预措施: Psychological questionnaires (Behavioral)
Placebo - Rear Base
1-month Placebo treatment following 4 months at rear base
干预措施: Photoplethysmography (Device)
Placebo - Rear Base
1-month Placebo treatment following 4 months at rear base
干预措施: Placebo (Drug)
结局指标
主要结局
Difference between the change in Burnout Assessment Tool (BAT) score following 1-month treatment in each arm
时间窗: After 1-month treatment
The Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out.
次要结局
- Difference between the change in catecholamine level following 1-month treatment in each arm(After 1-month treatment)
- Difference between the change in zonulin level following 1-month treatment in each arm(After 1-month treatment)
- Difference between the change in Interleukin-6 (IL6) level following 1-month treatment in each arm(After 1-month treatment)
- Difference between the change in Brain-Derived Neurotrophic Factor (BDNF) level following 1-month treatment in each arm(After 1-month treatment)
- Difference between the change in Tumor Necrosis Factor Alpha (TNFα) level following 1-month treatment in each arm(After 1-month treatment)
- Difference between the change in aminoacid level following 1-month treatment in each arm(After 1-month treatment)
- Difference between the change in gamma-aminobutyric acid (GABA) level following 1-month treatment in each arm(After 1-month treatment)