| CTRI Number |
CTRI/2025/08/092161 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between Dietary Diversity Physical activity and Muscle mass among elderly
Age group- ( 61-70) |
|
Scientific Title of Study
|
Relationship between Dietary Diversity Physical activity and Muscle mass among elderly
Age group- ( 61-70) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Bhekre |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Divya Rishi Apartment, 338, R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7506874837 |
| Fax |
|
| Email |
riyasbhekre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant procedure |
| Affiliation |
Smt PN Doshi Womens College |
| Address |
Smt PN Doshi Womens College Ghatkopar west Mumbai
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9869361456 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant procedure |
| Affiliation |
Smt PN Doshi Womens College |
| Address |
Smt PN Doshi Womens College Ghatkopar west Mumbai
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9869361456 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Riya Bhekre |
| 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 |
| Dr Rupali Sengupta |
Dr BMN College of Home Science |
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= 2 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Ethical Committee |
Approved |
| Seva Mandal Education Society Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
61.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both men and women aged 61 years or older
able to communicate
provide informed consent |
|
| ExclusionCriteria |
| Details |
Any condition that is severely affecting muscle function
severe cognitive impairment
Terminal illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the dietary diversity, nutrient intake and to assess the muscle mass in elderly |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the physical activity levels and to study the association between dietary diversity, nutrient intake, physical activity and muscle mass among elderly. |
5 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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="0"
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 study aims to explore the relationship between dietary diversity, physical activity, and muscle mass among elderly individuals aged 61 to 70 years. The primary objectives include assessing the participants’ dietary patterns and nutrient intake, evaluating their physical activity levels, and measuring their muscle mass to understand how these factors are interrelated. A descriptive study design will be used, with 100 elderly participants selected through convenience sampling. Data will be collected using a variety of tools: socio-demographic details such as age, gender, education, income, and medical history; anthropometric measurements including height, weight, BMI, waist-hip ratio, and calf circumference; and nutritional assessments through 24-hour dietary recall, food frequency questionnaires, and dietary diversity scores. Physical activity will be evaluated using the Global Physical Activity Questionnaire (GPAQ), while muscle strength and body composition will be measured using a handgrip dynamometer and a bioelectrical impedance analyzer (Tanita MA-420 BCA), respectively. Participants must be able to communicate and provide informed consent, while those with severe cognitive impairment, terminal illness, or conditions affecting muscle function will be excluded. This study aims to provide valuable insights into how lifestyle factors like diet and activity influence muscle health in the aging population. |