| CTRI Number |
CTRI/2025/07/091807 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Dietary Patterns, BMI and Muscle Strength in Women aged 40-60. |
|
Scientific Title of Study
|
Dietary Patterns, BMI and Muscle Strength in women (40-60) age group. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Virti Jayesh Shah |
| Designation |
Student |
| Affiliation |
Dr. Bhanuben Mahendra Nanavati College of Home Science |
| Address |
Dr.BMN College of Home Science, Department Of Clinical Nutrition and Dietetics, Divya Rishi Apartment,338,R.A. Kidwai Marg, Matunga East, Mumbai.
Dr.BMN College of Home Science, Department Of Clinical Nutrition and Dietetics, Divya Rishi Apartment,338,R.A. Kidwai Marg, Matunga East, Mumbai.
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8080385757 |
| Fax |
|
| Email |
virtishah85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monal Velangi |
| Designation |
Senior Dietitian |
| Affiliation |
K J Somaiya Hospital and Research Centre |
| Address |
2nd Floor, Chere View, L.N. road, Dadar East Mumbai.
Mumbai
MAHARASHTRA
400014
India |
| Phone |
9136097274 |
| Fax |
|
| Email |
dr.monalvelangi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monal Velangi |
| Designation |
Senior Dietitian |
| Affiliation |
K J Somaiya Hospital and Research Centre |
| Address |
2nd Floor, Chere View, L.N. road, Dadar East Mumbai.i
Mumbai
MAHARASHTRA
400014
India |
| Phone |
9136097274 |
| Fax |
|
| Email |
dr.monalvelangi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.BMN College of Home Science, Department of Clinical Nutrition and Dietetics, Divya Rishi Apartment, 338 R.A. Kidwai Marg,Matunga East, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Virti Jayesh Shah |
| Address |
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 |
| DrRuplai Sengupta |
Dr. BMN College of Home Science |
Dr.BMN College of Home Science, Department of Clinical Nutrition and Dietetics, Divya Rishi Apartment, 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 |
Age group 40-60 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Non-Working Women |
|
| ExclusionCriteria |
| Details |
Women below 40 years and above 60 years. Women who have recently undergone major surgery or medical interventions that impact muscle strength or abdominal obesity. Male participants of all age groups. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relationship between dietary patterns, BMI and muscle strength in women between 40 to 60 age group |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dietary patterns measured using food frequency questionnaire & 24 hour dieatry recall. BMI measured using calibrated tools for height & weight. Muscle strength measured using caliberated hand dynamometre |
6 weeks |
|
|
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)
|
05/08/2025 |
| 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="9"
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 study aims to assess the relationship between Dietary Patterns, BMI and Muscle Strength in women aged 40-60. The study will be conducted among 200 participants using purposive sampling. Data will be collected through calebrated tools that includes calebrated weighing machine, stadiometer, hand dynomometer, 24 hour dieatry recall along with a food frequency questionnaire. The findings of the study may provide how these 3 factors are interconnected and may affect womens health of 40-60 age group. |