| 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
|
|
|
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
|
|
|
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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