| CTRI Number |
CTRI/2025/09/094205 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Diet plan] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How intermittent fasting comparing regular diet affects weight in healthy adults with obesity in chengalpattu district |
|
Scientific Title of Study
|
Effect of intermittent fasting vs regular diet on weight reduction and biomarkers in healthy adults with obesity in Chengalpattu district: A randomized controlled trial. |
| Trial Acronym |
IF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
U Idayakshini |
| Designation |
Post graduate 2nd year |
| Affiliation |
SRM Medical College Hospital Research Centre |
| Address |
3rd floor D block Centre for Clinical Pharmacology SRM MCH RC KTR Campus Chengalpattu Dt. Tamil Nadu 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9081642447 |
| Fax |
|
| Email |
idyavishwakarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Melvin George |
| Designation |
Prof. Head, Centre for Clinical Pharmacology |
| Affiliation |
SRM Medical College Hospital Research Centre |
| Address |
3rd floor D block Centre for Clinical Pharmacology SRM MCH RC KTR Campus Chengalpattu Dt. Tamil Nadu 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9080281508 |
| Fax |
|
| Email |
melving@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Melvin George |
| Designation |
Prof. Head, Centre for Clinical Pharmacology |
| Affiliation |
SRM Medical College Hospital Research Centre |
| Address |
3rd floor D block Centre for Clinical Pharmacology SRM MCH RC KTR Campus Chengalpattu Dt. Tamil Nadu 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9080281508 |
| Fax |
|
| Email |
melving@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
U Idayakshini |
| Address |
3rd floor D block Centre for Clinical Pharmacology SRM MCH RC Kattankulathur campus chengalpattu Dt. 603001 Tamil Nadu India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Melvin George |
Centre for Clinical Pharmacology Sri Ramaswamy Memorial Medical college Hospital and Research Centre |
3rd floor D block Centre for Clinical Pharmacology SRM MCH RC KTR Campus Chengalpattu Dt., Tamil Nadu 603203.
Kancheepuram
TAMIL NADU |
9894133697
melving@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL - STUDENTS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group, regular diet |
participants of this group will be following a regular diet without any given specific diet regimen to be followed. participants of this group will be acting as a control to intervention group. Control study duration will be one month or 30 days |
| Intervention |
Diet plan and diet guidance |
intermittent fasting diet plan and guidance will be given to the participants randomized in intermittent fasting group. Intervention study duration will be one month or 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who are willing to participate and who are willing to provide consent to participate in the study.
b. Individuals of age 18 years to 45 years.
c. Either male or female.
d. Individuals with BMI above 25.
e. Individual should be in and around Chengalpattu region.
|
|
| ExclusionCriteria |
| Details |
Individual with cardiovascular diseases, metabolic disorders, diabetes mellitus, peptic ulcers, cognitive impairment, congenital anomalies, physically challenged, cancer, renal /liver impairment, pregnant and breastfeeding women or any eating disorders
b. Any Acute illness
c. HbA1c more than 6.5% .
d. Individual who underwent major surgical procedures in the last 3 months.
e. Individuals taking supplements or any other weight loss treatment such as ayurvedic, cryotherapy
f. Individuals who are engaged in gym activities, shift work, or heavy labor tasks.
g. Participation in another interventional trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in weight loss from baseline to week 4 in healthy adults with obesity.
|
Change in weight loss from baseline to week 4 in healthy adults with obesity.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in quality of life, lipid profile, well-being, fatigue in healthy adults with obesity.
|
Change in difference in the levels of biomarker (hsCRP) from baseline to week 4 in healthy adults with obesity
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2025 |
| 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="1"
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
|
Summary
Introduction
The proposed study will investigate intermittent fasting IF specifically the 16 hours of fasting and 8 window
period protocol as a non pharmacological intervention for obesity. In light of
the growing global obesity epidemic particularly in India where approximately
25 percentage of the population is overweight or obese the study will explore
the link between obesity and non communicable diseases NCDs such as diabetes
cardiovascular disease and mental health disorders. The 16 hours of fasting and
8 window period protocol which restricts food intake to an 8 hour window is
anticipated to improve fat metabolism enhance insulin sensitivity and reduce
inflammation via mechanisms such as ketogenesis and autophagy. The study will
build on existing evidence from previous research on various IF protocols including
alternate-day fasting and 5 days of fasting and 2 days of add libitum feed which
have demonstrated positive effects on weight management and biomarkers like
triacylglycerol C reactive protein and leptin.
Methodology
The study will be conducted as a randomized controlled trial
in Chengalpattu Tamil Nadu India and will recruit 40 participants aged 18 to 45
years with a BMI above 25. Participants will be screened using strict inclusion
and exclusion criteria to minimize confounding factors such as preexisting
metabolic disorders acute illness or involvement in other weight loss programs.
The trial will follow an open label design and eligible participants will be
randomized using block randomization with allocation concealment via SNOSE
envelopes.
Participants will be randomly assigned into two groups
The intervention group will follow the 16 hours of fasting and
8 hours of window period intermittent fasting protocol.
The control group will continue with their usual diet.
Both groups will receive dietary counselling weekly
telephonic follow-ups, and will be instructed to maintain diet diaries to
assess compliance. Adherence will be supported through mobile health
interventions with a minimum adherence threshold of 85 percentage set to ensure
the validity of outcomes.
Prior to randomization all
participants will undergo detailed baseline assessments which will include
Anthropometric measurements
Blood biomarker analysis including
high sensitivity C reactive protein or hsCRP
Body composition analysis using
the InBody770 device
Psychometric evaluations,
including
Short form 36 for quality of life
WHO-5 for psychological wellbeing
Fatigue Assessment Scale
Global Physical Activity
Questionnaire
Eating Disorder Examination
Questionnaire
Blood samples will be collected after a 7 to 8 hour fast on
Day 0 and Day 30 to assess fasting blood sugar lipid profile and hsCRP which is
a recognized biomarker of systemic inflammation and cardiovascular risk.
These comprehensive baseline and endpoint measures will
enable a multidimensional evaluation of the anticipated physiological and
psychological impacts of intermittent fasting in the study population.
|