| CTRI Number |
CTRI/2025/08/093401 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Diet in Enhancing Sleep Quality Among Older Adults |
|
Scientific Title of Study
|
The Role of Melatonin-Boosting Foods in Regulating Sleep Quality of the Elderly |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raina Qureshi |
| 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 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9137401146 |
| Fax |
|
| Email |
rainaqureshi03@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 |
Raina Qureshi |
| 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 |
Department of Clinical Nutrition and Dietetics, Divya Rishi Apartment 338 R A Kidwai Marg Matunga East 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Educartional Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individual with no disease condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
61.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Elderly aged 61-75 years
Individuals with self-reported sleep patterns and dietary habits
Not taking melatonin supplements or sleep medications
Willing to complete the survey and provide informed consent
|
|
| ExclusionCriteria |
| Details |
Individuals with diagnosed sleep disorders or chronic illnesses affecting sleep
Those on melatonin supplements or prescription sleep aids
Shift workers with irregular sleep schedules
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Role of Melatonin-Boosting Foods in Regulating Sleep Quality of the Elderly |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study sleep quality among the Elderly aged 61-75 years.
To study the prevalence of melatonin-rich food consumption among the Elderly aged 61-75 years.
To study the association between melatonin-boosting foods and sleep quality among the study participants.
|
At the Time of Data Collection |
|
|
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)
|
05/09/2025 |
| 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 is a cross-sectional observational study aimed at evaluating the association between the consumption of melatonin-boosting foods and sleep quality among elderly adults aged 61-75 years in Mumbai. Data will be collected through a self-administered questionnaire, including a Food Frequency Questionnaire (FFQ) and the Pittsburgh Sleep Quality Index (PSQI). The objective is to assess dietary intake patterns of melatonin-rich foods and their potential influence on sleep duration, quality. The findings may contribute to the development of non-pharmacological dietary interventions to improve sleep hygiene and support overall well-being in the elderly population. |