| CTRI Number |
CTRI/2024/08/073053 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Microgravity Simulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Resting Metabolic Rate microgravity |
|
Scientific Title of Study
|
To study the longitudinal variation in Resting Metabolic Rate and thermogenic effect of Standardized Food Regime during a 24 hr exposure to simulated microgravity condition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oommen Savina George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Bangalore
KARNATAKA
560017
India |
| Phone |
08025224131 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Oommen Savina George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Bangalore
KARNATAKA
560017
India |
| Phone |
08025224131 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Oommen Savina George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Bangalore
KARNATAKA
560017
India |
| Phone |
08025224131 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
|
Source of Monetary or Material Support
|
| DGAFMS AND DRDO
Ministry of Defence
New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
DGAFMS |
| Address |
Office of the DGAFMS Ministry of Defence Delhi 110001 |
| 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 Oommen Savina George |
Institute of Aerospace Medicine |
Simulation Microgravity Laboratory
Dept of Space and Environment Physiology
Institute of Aerospace Medicine
Vimanapura Post Bengaluru 560017
Bangalore
KARNATAKA |
08025224131
savinaoommen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Aerospace Medicine IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
24 hours Simulated microgravity |
24 hours simulated microgravity in the form of Dry Supine Immersion |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Healthy Volunteers |
|
| ExclusionCriteria |
| Details |
ECG PFT Abnormality
Acute Illnesses
Musculoskeletal Abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resting Metabolic Rate |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thermogenic effect |
2 hours after meals |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
15/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To study the longitudinal variation in Resting Metabolic
Rate and thermogenic effect of Standardized Food Regime during a 24 hours
exposure to simulated microgravity condition.
Objectives:
(i) To measure the measure the Basal
Metabolic Rate (BMR) in healthy subjects after 12 hours of overnight fasting.
(ii) Longitudinal measurement of Resting Metabolic
Rate (RMR) during 24 hrs of Dry Supine Immersion (DSI) and post DSI exposure.
(iii) To
study the thermogenic effect of a Standardized Dietary Regime during 24-hours
DSI. |