| CTRI Number |
CTRI/2022/06/043283 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
10/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dietary pattern and gastrointestinal health in middle aged adults |
|
Scientific Title of Study
|
Association between Dietary pattern and gastrointestinal health in middle aged adults residing in Mumbai city |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Doshi |
| Designation |
Student -M.Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Department of
Postgraduate studies in Clinical Nutrition and Dietetics,338,Rafi Ahmed Kidwai road Matunga
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8422841604 |
| Fax |
|
| Email |
mansidoshimd3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Department of Postgraduate studies in Clinical Nutrition and Dietetics,338,Rafi Ahmed Kidwai road, Matunga
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
900302531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Doshi |
| Designation |
Student -M.Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science Department of Postgraduate studies in Clinical Nutrition and Dietetics,338,Rafi Ahmed Kidwai road, Matunga
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8422841604 |
| Fax |
|
| Email |
mansidoshimd3@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 |
Mansi Doshi |
| Address |
Dr. BMN College of Home Science Matunga Department of
Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Mansi Doshi |
Dr. BMN College of Home Science |
Department of postgraduate studies in Clinical Nutrition and Dietetics ,Matunga, Mumbai 400019
Mumbai
MAHARASHTRA |
8422841604
mansidoshimd3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No medical history |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
36.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Middle aged adults 36 to 55 years both male and female residence of Mumbai city( Western and central zone of Mumbai) |
|
| ExclusionCriteria |
| Details |
Adults with no medical history, GI surgery, pregnant/ lactating or existing condition of gastrointestinal disorders and diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Understand dietary pattern on GI Health. It will help us to identify particular food responsible for GI symptoms and could contribute to a more individualized dietary advice.
Specific food groups which can benefit gut health and to create a list of food that could be excluded in specific GI concerns.
This study will help to identify dietary pattern in association with GI health which in future can be modifiable for intervention studies
|
Baseline Study |
|
|
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)
|
25/06/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- Aim: To evaluate association between dietary pattern and gastrointestinal health in middle aged adults residing in Mumbai city
1.To assess Gastrointestinal (GI) health in middle aged adults (36-55 years) residing in Mumbai city 2.To assess GI symptoms using gastrointestinal symptom rating scale (GSRS). 3.To assess dietary intake in middle aged adults using a food frequency questionnaire tool.
Study Design: Cross-sectional descriptive study Research type - Quantitative Research Target age group- Middle aged adults of 36-55 years Sample Size: 150
Sampling method - Non probability convenience sampling
Data collection will be in below format:- A. Consent and Demographic details B. Gastrointestinal symptoms rating scale C. Food frequency questionnaire tool Hypothesis: Null hypothesis - There is no association between dietary pattern and Gastrointestinal health in middle aged adults
|