| CTRI Number |
CTRI/2025/04/084420 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of COVID-19 on composition of body parameters in young adults |
|
Scientific Title of Study
|
Impact of COVID-19 on body composition analysis in young adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Tanvi Taya |
| Designation |
undergraduate |
| Affiliation |
Third year Mbbs student Kasturba medical college Manipal, MAHE Manipal Karnataka india |
| Address |
Kasturba Medical College, Manipal. Tiger Circle Road, Madhav Nagar, Eshwar Naga, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7015251925 |
| Fax |
|
| Email |
tayatanvi681@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chinmay Suryavanshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiology Kasturba Medical College Manipal |
| Address |
Department of Physiology
Kasturba Medical College, Manipal. Tiger Circle Road, Madhav Nagar, Eshwar Naga, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9902943613 |
| Fax |
|
| Email |
chinmay.as@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chinmay Suryavanshi |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiology Kasturba Medical College Manipal, Manipal Academy of Higher Education Manipal |
| Address |
Kasturba Medical College, Manipal. Tiger Circle Road, Madhav Nagar, Eshwar Naga, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9902943613 |
| Fax |
|
| Email |
chinmay.as@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiology, Kasturba Medical college Manipal, Tiger Circle, Madhavnagar, Eshwarnagar, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
ICMR STS |
| Address |
Indian Council of Medical Research Ministry of Health and Family Welfare, Govt. of India Ansari Nagar, New Delhi |
| 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 |
| Tanvi Taya |
Physiology Department Kasturba Medical College Manipal |
Kasturba Medical College, Manipal
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal,
Karnataka 576104
Kasturba Medical College, Manipal
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal,
Karnataka 576104
Udupi
KARNATAKA |
7015251925
tayatanvi681@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Past history of COVID-19 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: Participants from the general population having knowledge of English and aged between 18 and 30 years.
COVID-19 group: History of COVID-19 infection confirmed by RT-PCR or antigens test at least 1 year prior to the study will be included.
The control group will consist of age-matched individuals who did not have any signs or symptoms of COVID-19 and were not infected by COVID-19. |
|
| ExclusionCriteria |
| Details |
Active COVID-19 symptoms, autonomic imbalance, cardiovascular diseases, previously diagnosed neuropsychological disorders, or a history of severe COVID-related hospitalization |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extracellular water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body fat (in kg) and lean body mass (in kg): These parameters will also be expressed as percentages—body fat % and lean %. Fat-Free Mass Index (FFMI) Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBW) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBW. |
one year from 01-10-2024 to 01-10-2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Extracellular water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body fat (in kg) and lean body mass (in kg): These parameters will also be expressed as percentages—body fat % and lean %. Fat-Free Mass Index (FFMI) Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBW) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBW. |
one year from 01-10-2024 to 01-10-2025 |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, observational, cross-sectional study to compare body composition changes between COVID-19 survivors and non-infected individuals in the young adult population. To determine the prevalence and patterns of body composition changes in young adults following COVID-19 infections. The outcome measure will be Extracellular Water (ECW) and total body weight (TBW) will be measured using differential impedance at 50 kHz and 200 kHz, respectively. Subsequently, intracellular water (ICW) will be obtained by deduction of ECW from TBW. Body Fat (in kg) and Lean Body Mass (in kg): These parameters will also be expressed as percentages—Body Fat % and Lean %. Fat-Free Mass Index (FFMI) and Body Fat Mass Index (BFMI) will be derived from manufacturer-programmed predictive equations. In the analysis, hydration fractions obtained from regression equations will be used to calculate lean body mass (LBM) from total body weight (TBW). Fat mass will then be determined by the difference between TBW and LBM. |