| CTRI Number |
CTRI/2025/09/095220 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Body composition analysis and metabolic profile in adults involved in physical activity. |
|
Scientific Title of Study
|
body composition analysis and metabolic profile in adults involved in physical activity |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Hemanth B S |
| Designation |
Post graduate student |
| Affiliation |
Maulana azad medical college |
| Address |
Department of physiology
maulana azad maedical college new delhi
New Delhi
DELHI
110002
India |
| Phone |
6360472817 |
| Fax |
|
| Email |
hemanthbs1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR aarti sood mahajan |
| Designation |
HOD and Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of physiology
maulana azad medical college
new delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604301 |
| Fax |
|
| Email |
aartis_mahajan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR aarti sood mahajan |
| Designation |
HOD and Director professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of physiology
maulana azad medical college
new delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604301 |
| Fax |
|
| Email |
aartis_mahajan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana azad medical college, new delhi |
|
|
Primary Sponsor
|
| Name |
DR Hemanth B S |
| Address |
Department of physiology
maulana azad medical college
new delhi 110002 |
| Type of Sponsor |
Other [self] |
|
|
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 Hemanth B S |
Maulana azad medical college new delhi |
Department of physiology
maulana azad maedical college new delhi
New Delhi
DELHI |
06360472817
hemanthbs1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults of age 18 to 40 years and willing to volunteer for study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults of age 18 to 40 years and willing to volunteer for the study.
2.undergraduates and postgraduates students, senior residents, faculty and staff of maulana azad medical college and their relatives and friends. |
|
| ExclusionCriteria |
| Details |
1.Subjects with history of hypertension, diabetes, endocrine disease, cancer and orthostatic hypotension.
2.Tobacco users.
3.Subjects with long term drug use like metformin, diuretics.
4.Subjects with skeletal and muscular disorders.
5.Subjects who are unable to stand.
6.Subjects with large scars on the body.
7.Subjects with pacemaker or any other metallic implants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Association of physical activity levels and dietary intake on mean body fat percentage. |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Association of physical activity levels & dietary intake on thyroid hormone, adiponectin, lipid profile & Hba1c levels. |
Base line |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/10/2025 |
| 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="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
|
Body composition assessment categorizes an individual’s total body mass into fat mass and fat free mass with fat free mass consisting of muscles ,bones, organs, ligaments, tendons and water. Measuring the specific amount of fat, muscle, bone, and water provides critical information for the diagnosis, management, and treatment of numerous nutrition - related health conditions affecting both individuals and populations. Calorie restriction along with exercise boasts weight loss, lowers inflammation, and improves metabolic health. Therefore we need to understand in detail the role of physical activity and diet in body composition and metabolic profile in adults. |