| CTRI Number |
CTRI/2025/07/092119 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [KAP study] |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of what young adults in Mumbai know, think, and do about using protein supplements—between those who go to the gym and those who dont. |
|
Scientific Title of Study
|
Comparative study of Knowledge, Attitude, and Practice (KAP) regarding the use of protein supplements among gym-going and non-gym-going young adults 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 |
Sana Shaikh |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
09137956373 |
| Fax |
|
| Email |
sanashaikh942002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Anuradha Shekhar |
| Designation |
Retired Vice Principal and Head of FSN Department |
| Affiliation |
Retired Vice Principal and Head of FSN Department |
| Address |
A3/31 Shivaparvarti housing society , sector 21 Nerul Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Anuradha Shekhar |
| Designation |
Retired Vice Principal and Head of FSN Department |
| Affiliation |
Retired Vice Principal and Head of FSN Department |
| Address |
A3/31 Shivaparvarti housing society , sector 21 Nerul Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sana Shaikh |
| Address |
Dr BMN College of Home Science, Divya Rishi Apartment 338, R.A. Kidwai Road, Matunga, 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 |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, 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 cnditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing between gym goers and non gym goers |
we will compare the knowledge , attitude , practices among gym goers sample group and non gym goers sample group. Also getting to know the protein intake of both the groups. Either from protein supplements or from dietary intake. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Gym-goers
2.Residents of Mumbai
3.Willing to give informed consent.
4.Have used regularly for more than 6 months and are aware of protein supplements.
|
|
| ExclusionCriteria |
| Details |
1. Individuals other above 40 years of age and below 18 years of age
2. Unwilling to participate or incomplete responses.
3.Language barrier
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare knowledge, attitudes, and behaviors, the use of protein supplements used by gym-going population and non-gym-going young adults using self-reported questionnaires
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the nutritional status using anthropometric measurements (self-reported)
2. To analyze the nutritional status using a 24-hour Dietary Recall method
3. To evaluate the knowledge, attitude, & practice regarding protein supplements among the target population.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
11/08/2025 |
| 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="5"
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 is a cross-sectional observational study aimed at comparing the knowledge, attitude, and practice (KAP) regarding the use of protein supplements among gym-going and non-gym-going young adults aged 18-40 years in Mumbai. Data will be collected through a self-reported questionnaire. The objective is to assess awareness, perception, and consumption patterns of protein supplements across the two groups. The findings may help identify gaps in knowledge and inform future awareness programs or policy recommendations. |