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CTRI Number  CTRI/2024/06/069244 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [exercise intervention]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of combined home based exercise and aerobic exercise intervention on skinny fat young adult male participants 
Scientific Title of Study   Effect of home based exercise regimen in improving body composition and cardiometabolic parameters in young adults with normal weight 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  Dr Aditya Pradeep Karnad 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Physiology department, Kasturba Medical College and Hospital Manipal, Madhav Nagar, Manipal

Udupi
KARNATAKA
576102
India 
Phone  9980129891  
Fax    
Email  karnad.aditya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhiren D Punja 
Designation  Head of department 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  HOD, Physiology department, Kasturba Medical College and Hospital Manipal, Madhav Nagar, Manipal

Udupi
KARNATAKA
576102
India 
Phone  9845558131  
Fax    
Email  dhiren.punja@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Aditya Pradeep Karnad 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Physiology department, Kasturba Medical College and Hospital Manipal, Madhav Nagar, Manipal

Udupi
KARNATAKA
576102
India 
Phone  9980129891  
Fax    
Email  karnad.aditya@gmail.com  
 
Source of Monetary or Material Support  
MAHE Post graduate research grant, Research Directorate Office Manipal Academy of Higher Education Manipal - 576 104, Karnataka India  
 
Primary Sponsor  
Name  MAHE Post graduate research grant 
Address  Directorate of Research MAHE Grants office Ground Floor, Tower 3, Behind Melaka Manipal Medical College, (MMMC) Advanced Research Center, Manipal Academy of Higher Education, Manipal- 576104, India 
Type of Sponsor  Private medical college 
 
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 
Dr Aditya Pradeep Karnad  Kasturba Medical College Manipal  Amphibian lab, Physiology department
Udupi
KARNATAKA 
9980129891

karnad.aditya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy normal weight obese young adult males in the age group of 18-30 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combined Home based resistance and aerobic exercise regimen  Resistance training regimen consists of multiple home based body weight resistance exercises, which target multiple muscle groups with 2 days of the week consisting of multiple exercises. Aerobic exercises consists of jogging, walking or running according to the preference of the participant 
Comparator Agent  Control group  Control group will also undergo investigations as the exercise group, but they will not be performing the exercise regimen. After a duration of 12 weeks they will be followed up with the repeat of the investigations 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  1. Male participants will be taken from the student population of MAHE institution.
2. Participants will be from the ages of 18 to 30 years.
3. Participants with body fat percentage above 23.1%9 and with a BMI within the normal range– that is, above 18.5 kg/m2 to 24.9 kg/m2 (thus including both groups under normal weight and overweight categories).
4.Participants who have MET less than 4.0 will be included in the study after the participants answer the GPAQ questionnaire.
 
 
ExclusionCriteria 
Details  1. Participants having a history of cardiovascular disease and renal disease will be excluded from the study (as it interferes with the body composition assessment).
2. Participants will be excluded from the study if they are unable to perform the exercise regimen, due to musculoskeletal injury, cardiovascular disease history, etc,.
3. Participants having type I diabetes mellitus will be excluded from the study.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.BMI
2.Fat free mass
3.FFMI (index)
4.Body fat percentage
5.Body fat mass index(BFMI)
6.Waist/hip ratio
7.LDL, HLD, Serum triglycerides, total cholesterol
8. Fasting blood glucose, Fasting insulin, Insulin sensitivity (HOMA-IR)
9.Anthropometric measures such as waist circumference, hip circumference, waist to hip ratio and skin fold thickness at pectoral, abdomen and thigh
10. Blood pressure 
Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen 
 
Secondary Outcome  
Outcome  TimePoints 
1.Waist/hip ratio
2.LDL, HLD, Serum triglycerides, total cholesterol
3. Fasting blood glucose, Fasting insulin, Insulin sensitivity (HOMA-IR)
4.Anthropometric measures such as waist circumference, hip circumference, waist to hip ratio and skin fold thickness at pectoral, abdomen and thigh
5. Blood pressure 
Investigations will be performed at 0 weeks before start of the trial and repeated after 12 week combined exercise regimen 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   01/07/2024 
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 Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [karnad.aditya@gmail.com].

  6. For how long will this data be available start date provided 10-05-2025 and end date provided 10-05-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Studies have found that there is an increasing prevalence of obesity globally .There is also a similar growing prevalence of obesity in the Indian population . Studies have predicted that the prevalence of overweight will more than double among Indian adults aged 20–69 years between 2010 and 2040, while the prevalence of obesity will triple. And also as a result of which, there will be an increase in the prevalence of lifestyle related disorders such as cardiovascular disease and diabetes mellitus affecting not only an increased portion of the population but also a younger demographic. Obesity, which is defined based mainly on the Body mass index ( above range of >25 kg/m2 in the Indian population), has been associated with an increasing association with cardiovascular disease, insulin resistance and type II diabetes mellitus. Recent studies have also found that there is a strong association of abdominal adiposity and the complications associated with obesity such as diabetes mellitus, cardiovascular disease.

However, BMI as a tool does not differentiate between lean body mass and body fat percentage. As a result of which, a portion of the population who have a higher body fat percentage and a higher percentage of visceral fat (therefore associated with greater risks of morbidity and mortality) will not be screened and treated.

Normal weight obesity is defined as individuals with normal BMI (that is 18.9kg/m2 to 22.9kg/m2 and overweight under 23.0km/m2 to 24.9 kg/m2) that have an increased body fat percentage. There is a lack of literature on the incidence of normal weight obesity in the Indian population, who, due to their carbohydrate rich diet and increasingly sedentary lifestyle, are more prone to normal weight obesity.

There is also a lack of literature on the effects of exercise on the body composition of normal weight obesity individuals. Especially in the young adult population who are more prone to pick up the lifestyle habits. An increased involvement of physical exercise in the lifestyle of these individuals might be associated with reducing the incidence of non communicable diseases such as cardiovascular diseases and diabetes mellitus. The use of body fat percentage would also help identify the hidden part of the iceberg, consisting of cases who have a higher risk of suffering from non-communicable diseases that go undetected with an ineffective screening test like BMI.

 
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