| CTRI Number |
CTRI/2024/10/075573 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Comparative ] |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Digestive Symptoms in Obese and Non-Obese Adults in Mumbai: A FODMAP Diet Approach |
|
Scientific Title of Study
|
A comparative study on the digestive health of obese and non-obese adults in Mumbai based on GSRS and recommendations through FODMAP diet |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naba Imtiyaz Ahmed Ansari |
| Designation |
Student |
| Affiliation |
Dr. Bhanuben Mahendra Nanavati College of Home Science |
| Address |
Divya Rishi Apartment D Wing 9th Floor Room No. 903 338 R.A. Kidwai Road Matunga Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7039475950 |
| Fax |
|
| Email |
nabaansari2275@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Smt. P. N. Doshi Womens College |
| Address |
1st Floor Room No. 12 Home Science Department Jag Dhir Boda Vidya Sankul Cama Lane Ghatkopar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
9892974370 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Behel |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Smt. P. N. Doshi Womens College |
| Address |
1st Floor Room No. 12 Home Science Department Jag Dhir Boda Vidya Sankul Cama Lane Ghatkopar West Mumbai
Mumbai (Suburban)
MAHARASHTRA
400086
India |
| Phone |
9892974370 |
| Fax |
|
| Email |
amritabehel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Naba Imtiyaz Ahmed Ansari |
| Address |
Divya Rishi Apartment D Wing 9th Floor Room No. 903 338 R.A. Kidwai Road Matunga Mumbai |
| 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 Saad Ansari |
Dr. Bhanuben Mahendra Nanavati College of Home Science |
Divya Rishi Apartment D Wing 9th Floor Room No. 903 338 R.A. Kidwai Road Matunga Mumbai Maharashtra 400019
Mumbai
MAHARASHTRA |
9987629835
ansariimtiyaz6685@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Digestive health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Digestive Health and Dietary Habits |
Comparing the digestive health and dietary habit of obese and non-obese adults |
| Intervention |
FODMAP Diet Intervention |
Looking into obese and non-obese adults dietary pattern and accordingly recommending the FODMAP diet and counselling the participants
The intervention duration will be 3 Months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged 25 to 45 years.
2) Adults are classified into obese (BMI ≥ 23 kg/m²) and non-obese (BMI 18.5-22.9 kg/m²) groups.
3) Residing in Mumbai.
4) Voluntarily agrees to participate.
|
|
| ExclusionCriteria |
| Details |
1) Adults (less than 25 and more than 45 years of age ).
2) Individuals with serious health issues.
3) Individuals taking any drugs and medications that affect weight were excluded from the study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence and severity of gastrointestinal symptoms in obese and non-obese adults |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectively able to understand the digestive health of participants and their understanding of the GSRS questionnaire and FODMAP diet. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/11/2024 |
| 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="24"
Months="11"
Days="10" |
|
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
|
Digestive health is a critical component of overall well-being, significantly influenced by body weight and dietary habits. Obesity is a prevalent health issue in urban areas like Mumbai, potentially impacting digestive health. This study aims to compare the digestive health of obese and non-obese adults using the Gastrointestinal Symptom Rating Scale (GSRS) and explore the efficacy of the FODMAP diet in managing gastrointestinal symptoms.
|