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CTRI Number  CTRI/2024/08/072286 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of fasting & exercises on cholesterol & body fat in young obese adults 
Scientific Title of Study   Effect of Time Restricted Fasting Versus Aerobic Exercises on Serum Lipid Profile & Body Composition in Overweight & Obese young Adults A Randomized Control Trial 
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 Rajkiran Tiku 
Designation  Professor /HOD Cardio-Respiratory Physiotherapy  
Affiliation  college of Physiotherapy Tilak Maharashtra vidyapeeth deemed to be University  
Address  Department of Cardio-Respiratory Physiotherapy 6th floor,College of Physiotherapy,Tilak Maharashtra vidyapeeth Deemed to be university,Mukund Nagar ,Gultekdi, Pune

Pune
MAHARASHTRA
411037
India 
Phone  9983229228  
Fax    
Email  rajkiran.tiku@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Mukkamala  
Designation  Professor Musculoskeletal Physiotherapy  
Affiliation  college of Physiotherapy Sumandeep Vidyapeeth deemed to be University  
Address  College of Physiotherapy Department of Musculoskeletal Physiotherapy, G/f Sumandeep Vidyapeeth Deemed to be University at Po Piparia Ta waghodia,Dist Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Mukkamala  
Designation  Professor Musculoskeletal Physiotherapy  
Affiliation  college of Physiotherapy Sumandeep Vidyapeeth deemed to be University  
Address  College of Physiotherapy, Department of Musculoskeletal Physiotherapy G/F Sumandeep Vidyapeeth Deemed to be University at Po Piparia Ta waghodia,Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9898216184  
Fax    
Email  neha.cop@sumandeepvidyapeethdu.edu.in  
 
Source of Monetary or Material Support  
College of Physiotherapy, Department of cardio-respiratory Physiotherapy, 6th floor Tilak Maharashtra vidyapeeth deemed to be university, Mukund Nagar,Gultekdi pune Maharashtra ,411037 India  
 
Primary Sponsor  
Name  Dr Rajkiran Tiku 
Address  Professor/Hod Department of cardio-respiratory Physiotherapy, 6th floor College of Physiotherapy Tilak Maharashtra vidyapeeth deemed to be university ,Mukund Nagar,Gultekdi,Pune Maharashtra 411037 India  
Type of Sponsor  Other [self ] 
 
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 Rajkiran Tiku   College of Physiotherapy,Tilak Maharashtra vidyapeeth deemed to be university   Department of cardio-Respiratory Physiotherapy,A-wing,6th floor
Pune
MAHARASHTRA 
9983229228

rajkiran.tiku@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
institutional Ethics committee Tmvs college of Physiotherapy   Approved 
sumandeep Vidyapeeth institutional ethics committee al ethics   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overweight & obese young adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aerobic Exercise  Participants will engage in aerobic exercise for 40 to 60 minutes, three times a week, over the course of 12 weeks.  
Comparator Agent  Control group   participants not be required to follow any interventions such as time-restricted fasting or aerobic exercise; instead, solely on adhering to dietary restrictions for a period of 12 weeks.  
Intervention  Time Restricted Fasting   The 14:10 TRF protocol involves participants observing a 14-hour fasting period followed by a 10-hour eating window. This plan includes dietary restrictions for six days a week over the course of 12 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Young adults aged 18-30 years
overweight & obese individuals with a body mass index of more than 23-30 as per Asian BMI scale
Both Male & female
 
 
ExclusionCriteria 
Details  1.Individuals with a history of cardio-pulmonary disease/ surgery
2. Individuals with a history of Eating disorders
3. Pregnant or lactating females
4. Individuals using anti-diabetic, hypothyroidism, and dyslipidemia medications.
5.Individuals with any musculoskeletal abnormalities in the lower limbs, such as pain or recent surgery.
6.Individuals suffering from any acute infection & inflammation.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum Lipid Profile
 
sample will be collected before intervention & post intervention after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Body composition
Body fat
visceral fat  
sample will be collected before intervention & post intervention after 3 months and follow up after 3 months till 6 months will be continued 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   26/08/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The study is designed to tackle the significant issue of cardiovascular disease (CVD) risk factors in young adults who are overweight or obese. These individuals face a higher risk of developing CVD, which is a leading cause of morbidity and mortality worldwide. By focusing on this specific demographic, the research aims to provide targeted and effective interventions.Intermittent fasting, specifically time-restricted fasting, has gained attention for its potential health benefits, including weight loss and improvements in metabolic health. Aerobic exercise is also known to have positive effects on cardiovascular health, such as reducing blood pressure and improving lipid profiles. The study will explore how these interventions impact CVD risk factors, such as obesity, high blood pressure, and dyslipidemia, in young adults. It will not only assess the outcomes of intermittent fasting and aerobic exercise but also investigate the mechanisms through which these interventions exert their effects. This mechanistic understanding is crucial for developing tailored and effective interventions. By providing evidence-based recommendations, the study aims to inform healthcare providers and policymakers about the potential benefits of lifestyle interventions in managing CVD risk factors in young overweight and obese adults. Ultimately, the goal is to contribute to the development of strategies that can help reduce the burden of CVD in this vulnerable population.


 
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