| 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
|
|
|
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
|
|
|
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. |