| CTRI Number |
CTRI/2025/07/092013 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing the Relationship between Ultra-Processed Food Consumption and Metabolic Health in Young and Older Adults. |
|
Scientific Title of Study
|
A Comparative Study on the Association Between Ultra-Processed Food Consumption and Metabolic Health in Young and Older 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 |
Bushra Kamal Khan |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science, Matunga |
| Address |
DR.BMN College of Home Science, Department of Clinical Nutrition and Dietetics, Divya Rishi Apartment, Building No.338, R.A Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8433787881 |
| Fax |
|
| Email |
bushraakhan29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant Professor |
| Affiliation |
Smt.P.N.Doshi Womens College Ghatkopar |
| Address |
Smt.P.N.Doshi Womens College, Department of Food Science and Nutrition,Jag Dhir Boda Vidya, Sankul, Camalane,Ghatkopar West, Mumbai-400086
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9869361456 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant Professor |
| Affiliation |
Smt.P.N.Doshi Womens College Ghatkopar |
| Address |
Smt.P.N.Doshi Womens College, Department of Food Science and Nutrition, Jag Dhir Boda Vidya Sankul, Camalane, Ghatkopar West, Mumbai-400086
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9869361456 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Bushra Kamal Khan |
| Address |
DR.BMN College of Home Science Divya Rishi Apartment,338, R.A Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019 |
| 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 Rupali Sengupta |
Dr. BMN College of Home Science |
Department of Clinical Nutrition and Dietetics, Divya Rishi Apartment, 338, R.A. Kidwai Road, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Educational Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no diseased conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18-25 years and and 31-40 years
Voluntarily agreeing to participate in the study
Residing in Mumbai
|
|
| ExclusionCriteria |
| Details |
Age: Below 18 and Above 40
Pregnant or lactating women
Refusal to participate in the study
Those who are critically ill |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the association between ultra processed food consumption and metabolic health in young adults. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the ultra processed food consumption patterns among young and older adults residing in Mumbai.
2. To assess and compare the metabolic health status of the target population using anthropometric indicators and body composition analysis.
3. To evaluate and compare the association between UPF consumption and metabolic health outcomes in young and older adults. |
At the Time of Data Collection |
|
|
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)
|
10/08/2025 |
| 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="0"
Months="6"
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
|
This cross-sectional correlational study aims to compare the association between ultra- processed food consumption and metabolic health among young (18-25 years) and older adults (31-40 years) residing in Mumbai. A total of 200 participants will be selected using purposive convenience sampling (100 from each group). Data will be collected using validated tools including Food Frequency Questionnaire, a 3 day 24 hours dietary recall for dietary assessment, body composition analyzers for metabolic health evaluation, and the International Physical Activity Questionnaire (IPAQ) to assess physical activity levels. The findings may help identify age-specific dietary trends and inform public health strategies to reduce UPF intake and improved metabolic health outcomes in urban populations. |