| CTRI Number |
CTRI/2024/07/070667 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary and Lifestyle Modification] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Modified Intermittent Fasting and Lifestyle Modification in Patients with Obesity |
|
Scientific Title of Study
|
Evaluation of the Effect of Modified Intermittent Fasting and Lifestyle Modification in Patients with Obesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shraddha Tiwari |
| Designation |
Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Home Science, Mahila Mahavidhyalaya, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9506096735 |
| Fax |
|
| Email |
shraddhas935@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Lalit Prashant Meena |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839556651 |
| Fax |
|
| Email |
dr.lalitmeena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mukta Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Home Science, Mahila Mahavidhyalaya, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376623033 |
| Fax |
|
| Email |
drmuktasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Institute of Medical Sciences, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Shraddha Tiwari |
| Address |
Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi - 221005, Uttar Pradesh , India |
| 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 Lalit Prashant Meena |
Sir Sunderlal Hospital |
Department of General Medicine, Institute of Medical Science, Banaras Hindu University, Varanasi- 221005,
Varanasi
UTTAR PRADESH |
9839556651
dr.lalitmeena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No Intervention |
| Intervention |
Diet (Modified Intermittent Fasting), Lifestyle Modification |
Modified Intermittent Fasting( 5:2 Diet) for Obese patients and lifestyle modification. Duration of the Intervention : 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to undertake a dietary intervention for weight loss.
Subjects with obesity related health risks factors |
|
| ExclusionCriteria |
| Details |
Subjects with chronic disease like Cancer, Diabetes, CKD etc.
History of diagnosed eating disorder.
Respondents having severe complications.
Pregnant and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight loss
BMI
Central Obesity |
0 month,2 month, 4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometrics Measurements (Waist Circumference, MUAC, Hip waist ratio)
Pulse
BP
Lipid Profile
Blood Glucose Profile
CRP
Uric acid |
0 month, 2 month, 4 month |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="1"
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
|
It is Randomized control trial study. This study is undertaken to assess the nutritional status, food consumption pattern and bio chemical investigation ( Lipid profile, blood glucose profile, HbA1c, CRP, uric acid) of obese patients. The intervention phase of the present study will include dietary (5:2 Intermittent fasting, 5:2 diet consists of two non-consecutive days per week of significant energy restriction (500 kcal for women and 600 kcal for men ) and lifestyle modification for the selected respondents using diet charts, booklets, folders.. After intervention observe the impact of 5:2 intermittent fasting and lifestyle modification on weight loss, abdominal obesity and biochemical parameters of respondents. Follow up after a period of eight weeks from the first follow up. |