CTRI Number |
CTRI/2023/10/058773 [Registered on: 17/10/2023] Trial Registered Prospectively |
Last Modified On: |
13/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
To study the influence of dinner timings on gastrointestinal symptoms and sleep quality |
Scientific Title of Study
|
To Study the Influence of Dinner Timings on Gastro-intestinal symptoms and Sleep Quality |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Riddhi Mehta |
Designation |
Student |
Affiliation |
Dr BMN College of Home Science |
Address |
Dr BMN College of Home science
338, Rafi Ahmed Kidwai road, Matunga East
Mumbai MAHARASHTRA 400019 India |
Phone |
8433534027 |
Fax |
- |
Email |
riddhimehta44@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rupali Sengupta |
Designation |
Head of department of MSc in clinical nutrition and dietetics |
Affiliation |
Dr BMN College of Home Science |
Address |
Dr BMN College of Home science 338, Rafi Ahmed Kidwai road, Matunga East Mumbai
Mumbai MAHARASHTRA 400019 India |
Phone |
9892415789 |
Fax |
|
Email |
rupali@bmncollege.com |
|
Details of Contact Person Public Query
|
Name |
Riddhi Mehta |
Designation |
Student |
Affiliation |
Dr BMN College of Home Science |
Address |
Dr BMN College of Home science 338, Rafi Ahmed Kidwai rd, Matunga East - Mumbai MAHARASHTRA 400019 India |
Phone |
8433534027 |
Fax |
- |
Email |
riddhimehta44@gmail.com |
|
Source of Monetary or Material Support
|
Dr. BMN College of Home Science Matunga Department of postgraduate studies in clinical Nutrition and dietetics |
|
Primary Sponsor
|
Name |
Riddhi Mehta |
Address |
Dr BMN college of Home science
338, Rafi Ahmed Kidwai rd, Matunga East Mumbai, Maharashtra 400019 |
Type of Sponsor |
Other [Self sponsered] |
|
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 |
Riddhi mehta |
Dr BMN College of Home Science |
Dr BMN College of Home science 338, Rafi Ahmed Kidwai road, Matunga East Mumbai Mumbai MAHARASHTRA |
8433534027
riddhimehta44@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
No pre-existing GI disorder or sleep disorder |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Both |
Details |
individuals belonging to age group belonging to 20 to 40 years would be selected from Mumbai residence and are willing to participate in study. |
|
ExclusionCriteria |
Details |
participants with pre-existing GI disorders or sleep disorders, pregnant women, living outside Mumbai |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Findings from the study will contribute to the knowledge of the relationship between dinner timings, GI health, and sleep quality.Depending on the results this research could have practical implications for Dietary recommendations, optimizing sleep patterns, overall health and well-being. |
at baseline |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
23/10/2023 |
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
|
AIM To Study the influence of dinner timings
on Gastrointestinal symptoms and Sleep quality of people (age group 20- 40
years) in Mumbai city. OBJECTIVES
- To Evaluate
common symptoms of gastrointestinal disorders using a gastrointestinal
symptom rating scale.
- To
assess the sleep quality using the Pittsburgh Sleep Quality Index-PSQI.
- To
assess meal(dinner) timings and questions pertaining to their health and
lifestyle habits using a questionnaire
- To
Study the association of dinner timings with gastrointestinal symptoms and
sleep quality.
|