| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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. |