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CTRI Number  CTRI/2022/11/046969 [Registered on: 01/11/2022] Trial Registered Prospectively
Last Modified On: 01/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effects tyrosine nutraceutical bar (CognoBar) on cognitive function in stressful environment 
Scientific Title of Study   Operational Preparedness under Extreme Environments (OPEX): Enhancing cognitive performance at high altitude using CognoBar 
Trial Acronym  CognoBar 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishna Kishore 
Designation  Scientist-E 
Affiliation  Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization 
Address  Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization, Ministry of Defence, Govt. of India, Lucknow Road, Timarpur, Delhi-110054

North
DELHI
110054
India 
Phone  011-23883206  
Fax  011-23914790  
Email  kishu16in@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishna Kishore 
Designation  Scientist-E 
Affiliation  Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization 
Address  Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization, Ministry of Defence, Govt. of India, Lucknow Road, Timarpur, Delhi-110054

North
DELHI
110054
India 
Phone  011-23883206  
Fax  011-23914790  
Email  kishu16in@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Somnath Singh 
Designation  Scientist-F 
Affiliation  Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization 
Address  Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization, Ministry of Defence, Govt. of India, Lucknow Road, Timarpur, Delhi-110054

North
DELHI
110054
India 
Phone    
Fax    
Email  nutrition.dipas@gov.in  
 
Source of Monetary or Material Support  
Defence Institute of Physiology and Allied Sciences, Defence Research and Development Organization, Ministry of Defence, Govt. of India 
 
Primary Sponsor  
Name  Defence Institute of Physiology and Allied Sciences Defence Research and Development Organization 
Address  Lucknow Road, Timarpur, Delhi 110054 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dharmendra Kumar  Biochemistry Laboratory, High Altitude Medical Research Centre, 153 General Hospital  C/o 153 General Hospital, C/o 56 APO Leh (Ladakh)
Leh (Ladakh)
JAMMU & KASHMIR 
9765534896
23092931
oichamrcleh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male low landers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CognoBar (Tyrosine Nutraceutical Bar)  CognoBar (Tyrosine nutraceutical bar) at a dose of 6.5 g tyrosine, once on the day of recording, will be supplemented to the participants at high altitude and very high altitude 
Comparator Agent  Placebo bar  Place bar (without Tyrosine) will be supplemented to the participants, once on the day of recording at high altitude and very high altitude 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  Medical History:SHAPE-I
Weight: 65±2 Kg 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of CognoBar (Tyrosine nutraceutical bar) on Cognitive function at High Altitude (11000 to 12000 feet)  8-10 week after High altitude induction 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

st degree of mental and physical alertness is imperative among combat soldiers to accomplish successfully complex military missions often under the most adverse and hostile environments. A multitude of physical stressors such as extreme cold, high altitude (HA), heat, noise, vibration etc., and physiological stressors such as sleep deprivation, fear, loneliness etc., are likely to impair the performance and decision making during complex situations. Therefore, a non-pharmacological substance such as a normal food constituent with the potential to reduce or reverse the stress response would not only be useful to military combatants but other patients of stress related disorders too. Therefore, studies are needed to evaluate potential performance enhancing food components in the normal ration of the soldiers which if added to the diet could develop stress resistance amongst the soldiers.  

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

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

Total no. of participants          :           400 (in two batches)

Batch I (High altitude 11000 to 12000 feet): 200 participants

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

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

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


 
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