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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No pre-existing GI disorder or sleep disorder 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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  
Outcome  TimePoints 
NA  NA 
 
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

  1. To Evaluate common symptoms of gastrointestinal disorders using a gastrointestinal symptom rating scale.
  2. To assess the sleep quality using the Pittsburgh Sleep Quality Index-PSQI.
  3. To assess meal(dinner) timings and questions pertaining to their health and lifestyle habits using a questionnaire
  4. To Study the association of dinner timings with gastrointestinal symptoms and sleep quality.
 
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