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CTRI Number  CTRI/2024/11/076785 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of chrono nutrition and metabolic health in young adults (20-30 years) in Mumbai 
Scientific Title of Study   Association of chrono nutrition and metabolic health among young adults (20-30 years) in Mumbai 
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 Amrita Behel 
Designation  Assistant Professor 
Affiliation  Smt P N Doshi Womens College 
Address  Staff Room, 1st Floor, Jag Dhir Boda Vidya Sankul, Camalane, Ghatkopar West, Mumbai

Mumbai
MAHARASHTRA
400086
India 
Phone  9869361456  
Fax    
Email  amritabehel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Harshada Paliwal 
Designation  Student 
Affiliation  Dr. Bhanuben Mahendra Nanavati College of Home Science 
Address  Room No. 903, 9th Floor, Dr. Bhanuben Mahendra Nanavati College of Home Science, Rafi Ahmed Kidwai Road, Matunga
NA
Mumbai
MAHARASHTRA
400019
India 
Phone  9130462048  
Fax    
Email  harshadapaliwal3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amrita Behel 
Designation  Assistant Professor 
Affiliation  Smt P N Doshi Womens College 
Address  Staff Room, 1st Floor, Jag Dhir Boda Vidya Sankul, Camalane, Ghatkopar West, Mumbai


MAHARASHTRA
400086
India 
Phone  9869361456  
Fax    
Email  amritabehel@gmail.com  
 
Source of Monetary or Material Support  
Room No. 901, 9th Floor, Dr Bhanuben Mahendra Nanavati Collge of Home Science, Matunga, Mumbai 400019 
 
Primary Sponsor  
Name  Harshada Paliwal 
Address  Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samir Raorane  Diya’s Construction Co.  1st floor, 181-Megh, Megh Malhar Complex, Gen. A.K. Vaidya Marg. Dindoshi Bus Depot, Goregaon (East), Mumbai – 400063
Mumbai
MAHARASHTRA 
7666230638

sindhugawas@gmail.com 
Dr Avinash Tiwari  Hindustan Construction Company Limited  Room No. 2, 1st Floor, HCC Ltd., Hincon House, L.B.S Marg, Gandhi Nagar, Vikhroli West, Mumbai 400079
Mumbai
MAHARASHTRA 
956108166

avi.paliwal1973@gmail.com 
Dr Mayankeshwar Singh  Imperial Auto LLP  Shop No. 16, 17, Mira Bhayandar Link Road, Near Old Petrol Pump, Mira Bhayandar, Mumbai 401107
Mumbai
MAHARASHTRA 
7757081366

tinapaliwal2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seva Mandal Education Societys Institutional Ethical Committee (IEC) 338 R. A Kidwai Road Matunga, Mumbai 19  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently healthy young adults (both males and females) aged between 20 to 30 years Young adults residing in Mumbai. Participants without chronic illnesses. 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Apparently healthy young adults (both males and females) aged between 20 to 30 years young adults residing in Mumbai.
Participants without chronic illnesses.
 
 
ExclusionCriteria 
Details  Participants below 20 or above 30 years.
Adults with known health conditions 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Chrononutrition is likely to be associated with metabolic health parameters of young adults and may therefore be an important consideration in modulating health outcomes of young adults.  4 Months 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   23/11/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The aim of the study is to find the association between chrono nutrition and metabolic health among young adults (20 -30 years) in Mumbai. The objectives of the study are to assess meal time and meal frequency of the young adults (21 – 30 years), to identify chronotype of subjects based on their meal timing and meal frequency, to assess metabolic health parameters of the subjects, to study the association between the chrono nutrition and metabolic health parameters. The purpose of this study is to study the association between the chrono nutrition and metabolic health of young adults living in Mumbai. In this fast-evolving landscape of the urban world of today, the concern over the relation of chrono nutrition with metabolic health calls for some fundamentally based research. This is one of the important areas of concern which needs to be understood deeply as to how meal timing can impact the metabolic health of the young adults of Mumbai. It would lay the foundation for designing effective preventive strategies that could counteract the increasing incidence of metabolic disorders within the age group of the study subjects. This study will give knowledge in the area of meal timing-related lifestyle modifications that may improve young adults’ health outcomes and well-being in Mumbai.

 
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