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CTRI Number  CTRI/2024/11/077466 [Registered on: 28/11/2024] Trial Registered Prospectively
Last Modified On: 28/04/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of body fat,protein and mineral mass in women participants of different age. 
Scientific Title of Study   Comparison of body composition in reproductive age group, menopausal transition and postmenopausal Indian women. 
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 Aarti Sood Mahajan 
Designation  Director Professor and HOD 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Department of Physiology, Maulana Azad Medical College New Delhi

Central
DELHI
110002
India 
Phone  9968604301  
Fax    
Email  aartis_mahajan@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Aarti Sood Mahajan 
Designation  Director Professor and HOD 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Department of Physiology, Maulana Azad Medical College 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  Director Professor and HOD 
Affiliation  Maulana Azad Medical College, New Delhi 
Address  Department of Physiology, Maulana Azad Medical College New Delhi


DELHI
110002
India 
Phone  9968604301  
Fax    
Email  aartis_mahajan@yahoo.co.in  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, Bahadurshah Zafar Marg, New Delhi-110002 India 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Department of Physiology, Maulana Azad Medical College New Delhi 
Type of Sponsor  Government medical college 
 
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 Aarti Sood Mahajan  Maulana Azad Medical College  Department of Physiology Maulana Azad Medical College, New Delhi
Central
DELHI 		 9968604301

aartis_mahajan@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  women in reproductive age groups, menopausal transition and post-menopausal women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Women greater than 30 years.
2. Expressing a willingness to participate in the study.
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. If the patient has been implanted with pacemaker
3. Women with any current serious disorders, such as stroke, cardiac disease, chronic renal failure, or peripheral arterial disease, cancerous, psychiatric, or inflammatory diseases and on hormonal replacement therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Total body water in women of reproductive age group, women in menopausal transition and postmenopausal women.
2. Body weight, body mass index, protein mass(kg), mineral mass (kg), muscle mass (kg), fat mass (kg),body fat (%), visceral fat level, abdominal fat ratio in women of reproductive age group, women in menopausal transition and postmenopausal women.
3. Segmental fat mass and muscle mass (kg) in left and right arm, left and right leg and trunk in women of reproductive age group, women in menopausal transition and postmenopausal women.
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of parameters of Total body water (l), body weight (kg), protein mass (kg), mineral mass (kg), muscle mass (kg), fat mass (kg), body mass index, body fat (%), visceral fat level, abdominal fat ratio and segmental fat mass and muscle mass (kg) in left and right arm, left and right leg and trunk in women of reproductive age group, women in menopausal transition and postmenopausal women.  Baseline 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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 study will be conducted in the Department of Physiology, Maulana Azad Medical College, New Delhi. The aim of the study is to find out the Body composition in Reproductive age group women, those undergoing menopausal transition and Post menopausal Indian women. This will be compared to find out whether body composition analysis parameters can be an independent risk factor for Lifestyle related disorders.
 
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