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CTRI Number  CTRI/2026/03/105523 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 05/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Effect of High Intensity Exercise on Blood Glucose in Overweight and Obese Adults 
Scientific Title of Study   High Intensity Interval Training on Overweight and Obese Individuals and its effect on Insulin Sensitivity: A Pre and Post Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prachitha D M 
Designation  MBBS Phase III Part I Student 
Affiliation  JSSAHER, Mysuru 
Address  School of Public Health, JSS Medical College, JSS Academy of Higher Education and Research, Bannimantap A Layout, Bannimantap, Mysuru, Karnataka

Mysore
KARNATAKA
570015
India 
Phone  8277114268  
Fax    
Email  23M01163@jssuni.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Anil S Bilimale 
Designation  Associate Professor and Chief Program Coordinator 
Affiliation  JSSAHER, Mysuru 
Address  School of Public Health, JSS Medical College, JSS AHER, Mysuru

Mysore
KARNATAKA
570015
India 
Phone  9880709226  
Fax    
Email  anilbilimale@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  Prachitha D M 
Designation  MBBS Student 
Affiliation  JSSAHER, Mysuru 
Address  JSS Medical College, Bannimantap A Layout, Bannimantap, Mysuru, Karnataka

Mysore
KARNATAKA
570015
India 
Phone  8277114268  
Fax    
Email  23M01163@jssuni.edu.in  
 
Source of Monetary or Material Support  
ICMR STS 2025 ID: STS2025-13848 
 
Primary Sponsor  
Name  ICMR 
Address  Indian Council of Medical Research, AIIMS Campus Temple, Ansari Nagar East, New Delhi, Delhi 110029 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Principal Investigator  JSS Hospital  School of Public Health, Old OPD building, Mahatma Gandhi Road, Fort Mohalla, Mysuru, Karnataka, 570004
Mysore
KARNATAKA 		 8277114268

23M01163@jssuni.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overweight and Obese Individuals aged 18-50 years  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Intensity Interval Training  HIIT Intervention Protocol The intervention will consist of a 8-week progressive HIIT program conducted 2 sessions per week (16 total sessions) under supervised conditions. The protocol will be adapted from established HIIT frameworks. Weeks 1-2 (Adaptation Phase) - Warm-up: 5 minutes moderate intensity (60-70% HRmax) - Work intervals: 30 seconds high intensity (85-90% HRmax) - Recovery intervals: 90 seconds active recovery (50-60% HRmax) - Number of intervals: 6-8 repetitions - Cool-down: 5 minutes low intensity Weeks 3-6 (Intensification Phase) - Warm-up: 5 minutes moderate intensity - Work intervals: 30 seconds high intensity (90-95% HRmax) - Recovery intervals: 60 seconds active recovery - Number of intervals: 8-10 repetitions - Cool-down: 5 minutes low intensity Weeks 7-8 (Peak Phase) - Warm-up: 5 minutes moderate intensity - Work intervals: 45 seconds high intensity (90-95% HRmax) - Recovery intervals: 60 seconds active recovery - Number of intervals: 8-10 repetitions - Cool-down: 5 minutes low intensity 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  - Adults aged 18-50 years
- Body Mass Index (BMI) greater than or equal to 23 kg/m² (overweight) or greater than or equal to 27 kg/m² (obese) according to Extended
International (IOTF) Body Mass Index Cut-Offs.
- Sedentary lifestyle (any waking behavior characterized by an energy expenditure of 1.5 METs
or less while in a sitting, reclining, or lying posture) (Physical Activity Guidelines Advisory
Committee, 2018)
- Ability to provide informed consent.
- Medical clearance for high-intensity exercise participation. 
 
ExclusionCriteria 
Details  Diagnosed cardiovascular disease, uncontrolled hypertension (greater than 160/100 mmHg), or cardiac
arrhythmias
- Type 1 diabetes mellitus or insulin-dependent Type 2 diabetes mellitus
- Musculoskeletal injuries or conditions limiting exercise participation
- Pregnancy or lactation
- Current participation in structured exercise programs
- Use of medications significantly affecting glucose metabolism (excluding stable doses of
metformin)
- Recent weight loss surgery (less than 12 months) or current enrollment in weight loss programs 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Venous blood samples will be collected following a 12hr overnight fast at baseline and post-intervention Fasting Glucose levels will be analyzed using hexokinase method and Fasting Insulin levels will be analysed using Electrochemiluminiscence immunoassay  screening anthropometric measurements body composition analysis Insulin Sensitivity Muscle mass will be recorded at Baseline week 0 visit 1 and post 48 hours Visit 2 Post intervention assessment similar to baseline procedures at Week 9 
 
Secondary Outcome  
Outcome  TimePoints 
Anthropometric measurements: height, weight, BMI, waist circumference
- Resting heart rate & blood pressure
- Body fat percentage (via BIA InBody analysis)
 		 anthropometric measurements, resting heart rate & blood pressure will be recorded at Baseline week 0 visit 1 & post 48 hours Visit 2 Post intervention assessment similar to baseline procedures at Week 9 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   30/04/2026 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [23M01163@jssuni.edu.in].

  6. For how long will this data be available start date provided 01-01-2030 and end date provided 01-01-2045?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study’s outcomes will suggest that incorporating just 30 minutes of high-intensity interval training (HIIT) into regular exercise routines can significantly improve cardiorespiratory fitness in overweight and obese individuals. This has important public health implications, as it provides an efficient, time-effective intervention for improving cardiovascular health and potentially reducing the risk of chronic diseases associated with obesity. Moreover, it highlights HIIT as a viable alternative to longer-duration moderate-intensity workouts, which may enhance adherence among individuals with limited time or motivation 
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