跳至主要内容
临床试验/CTRI/2022/11/046969
CTRI/2022/11/046969尚未招募2 期

Operational Preparedness under Extreme Environments (OPEX):Enhancing cognitive performance at high altitude using CognoBar

Defence Institute of Physiology and Allied Sciences Defence Research and Development Organization1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
Effect of CognoBar (Tyrosine nutraceutical bar) on Cognitive function at High Altitude (11000 to 12000 feet)

研究概览

简要总结

st degree of mental andphysical alertness is imperative among combat soldiers to accomplishsuccessfully complex military missions often under the most adverse and hostileenvironments. A multitude of physical stressors such as extreme cold, highaltitude (HA), heat, noise, vibration etc., and physiological stressors such assleep deprivation, fear, loneliness etc., are likely to impair the performanceand decision making during complex situations. Therefore, a non-pharmacologicalsubstance such as a normal food constituent with the potential to reduce orreverse the stress response would not only be useful to military combatants butother patients of stress related disorders too. Therefore, studies are neededto evaluate potential performance enhancing food components in the normalration of the soldiers which if added to the diet could develop stressresistance amongst the soldiers.

CognoBar (Tyrosine nutraceutical bar) will help to improve the cognitiveperformance of the army personnel deployed in high altitude environment.

400 number participantsfrom Indian Army will participate in the study.   The study will beconducted in two batches of 200 participants in each batch i.e. total 400participants.

Total no. ofparticipants          :           400(in two batches)

Batch I (High altitude11000 to 12000 feet): 200 participants

Batch II (Very highaltitude 13000 to 14000 feet): 200 participants

Baseline recordings of all the parameters will be conducted at sealevel.  Participants will then be inducted to high altitude (11,000 ft to 12,000 ft.) and Very highaltitude (13000 to 14000 feet). Altitude studies will be carried out after 8-10week of induction.

**Supplementation:**CognoBar (Tyrosine nutraceutical bar) will besupplemented to the participants at high altitude and after 90 min of tyrosinesupplementation all the parameters will be recorded.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Male

入选标准

  • Medical History:SHAPE-I Weight:65±2 Kg.

排除标准

  • Free from any neurological disorder and cardiac problems and would not be taking any sort of psychotropic, psychoactive or any other medication during the course of the study.

结局指标

主要结局

Effect of CognoBar (Tyrosine nutraceutical bar) on Cognitive function at High Altitude (11000 to 12000 feet)

时间窗: 8-10 week after High altitude induction

次要结局

  • Effect of CognoBar (Tyrosine nutraceutical bar) on Cognitive function at Very High Altitude (13000 to 14000 feet)(8-10 week after Very High altitude induction)

研究者

发起方
Defence Institute of Physiology and Allied Sciences Defence Research and Development Organization
申办方类型
Government funding agency

研究点 (1)

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