| CTRI Number |
CTRI/2022/04/041860 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dietary Factors and Digestive Health of Adults residing in Mumbai City.
|
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Scientific Title of Study
|
Understanding the Association of Dietary Factors and Digestive Health of 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 |
Oume Ummara Rajapurkar |
| Designation |
Student - M.Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College |
| Address |
Dr. BMN College of Home Science Matunga Department of Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai
MAHARASHTRA
400070
India |
| Phone |
7678037822 |
| Fax |
|
| Email |
amykhan274@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
Assistant Professor |
| Affiliation |
Dr. BMN College |
| Address |
Dr. BMN College of Home Science Matunga Department of Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai
MAHARASHTRA
400019
India |
| Phone |
900302531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Oume Ummara Rajapurkar |
| Designation |
Student - M.Sc. in Clinical Nutrition and Dietetics |
| Affiliation |
Dr. BMN College |
| Address |
Dr. BMN College of Home Science Matunga Department of Postgraduate studies in Clinical Nutrition and Dietetics
Mumbai
MAHARASHTRA
400070
India |
| Phone |
7678037822 |
| Fax |
|
| Email |
amykhan274@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 |
Oume Ummara Rajapurkar |
| Address |
Dr. BMN College of Home Science Matunga Department of Postgraduate studies in Clinical Nutrition and Dietetics |
| 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 |
| Oume Ummara Rajapurkar |
Dr. BMN College of Home Science |
Department of Postgraduate studies in Clinical Nutrition and Dietetics, Matunga, Mumbai 400019
Mumbai
MAHARASHTRA |
7678037822
amykhan274@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No medical history |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 50 years
Residence of Mumbai |
|
| ExclusionCriteria |
| Details |
No Medical history or existing condition of Gastrointestinal diseases and disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Association between intake of beneficial dietary factors such as probiotics, prebiotics, dietary fibre, and polyphenols and a good digestive health and factors in the diet that cause poor digestive health e.g. unhygienic environment.
|
At baseline |
|
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Secondary Outcome
|
|
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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)
|
15/04/2022 |
| 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="4"
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 understand the association between the dietary factors influencing gastrointestinal symptoms and digestive health in Adults.
Objectives: - To assess the dietary intakes of Adults residing in Mumbai City.
- To evaluate digestive health using the Gastrointestinal Symptoms Rating Scale (GSRS).
- To find an association between the dietary factors influencing gastrointestinal symptoms and digestive health of adults residing in Mumbai city.
Materials and Methods: This is a cross-sectional study which aims to investigate the beneficial and harmful dietary factors relating to gastrointestinal health of adults residing in Mumbai. It will be done by administering a semi-structured questionnaire through an online survey (Google Form) including behavioural questions and a Food Frequency Questionnaire (FFQ) for assessing the intake. The questionnaire will also include questions regarding the source of foods to know whether it is home-cooked and prepared with the required hygiene or prepared in unhygienic conditions commonly seen in fast-food shops. The evaluation of digestive health will be done by scoring method using the Gastrointestinal Symptoms Rating Scale (GSRS). The questionnaire will be divided into 4 sections including questions regarding - (i) Demographic variables, (ii) Diet and Lifestyle (iii) FFQ (iv) Gastrointestinal symptoms. - Research Type - Quantitative Research
- Research Design - Cross-sectional Study
- Sample Size - 100 subjects
- Target Group - Adults residing in Mumbai
- Sampling method - Snowball Sampling
Hypothesis: There is no association between dietary factors influencing gastrointestinal symptoms and digestive health. |