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CTRI Number  CTRI/2025/10/095768 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Sweat Biomarkers in Recreational Athletes 
Scientific Title of Study   Sweat Based Biomarker Profiling Among Recreational Athletes-A Cross Sectional 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  Gurpreet Singh  
Designation  BPT Intern  
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9606522003  
Fax    
Email  gurpreet.singh12@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Kumar Sinha 
Designation  Assistant Professor-Selection Grade 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal
Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9535679047  
Fax    
Email  mukesh.sinha@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh Kumar Sinha 
Designation  Assistant Professor-Selection Grade 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, MCHP, MAHE, Manipal
Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9535679047  
Fax    
Email  mukesh.sinha@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, MCHP, MAHE, Manipal 576104 
 
Primary Sponsor  
Name  Gurpreet Singh 
Address  Department of Physiotherapy, MCHP,MAHE, MANIPAL 576104 
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 
Gurpreet Singh   Department of Physiotherapy  3rd floor, Room No. 308 Cardiopulmonary Physiotherapy Lab, Kasturba Hospital Department of Physiotherapy, MAHE, Manipal 576104
Udupi
KARNATAKA 
9606522003

gurpreet.singh12@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE - 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Recreational athletes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  1. To be training in physical activity aiming to improve his or her health.
2. Training at least 3-5 days per week in a structured and planned manner.
3. Each training session often exceeding 60 minutes including a mix of aerobic, anaerobic, strength or skill based training.
4. must be training in the above format for at least 3 months.
 
 
ExclusionCriteria 
Details  1. Non recreational athletes.
2. Current case of cardiovascular, respiratory and neurological conditions.
3. History of recent musculoskeletal injury that has not fully healed.
4. Any active pain that limits your performance in the test.
5. Sickness that may worsen due to participation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
sweat based biomarkers   Two time points in one day(Pre and post exercise test) with a time difference of 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="61"
Sample Size from India="61" 
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)   01/11/2025 
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="6"
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  
The study titled Sweat Based Biomarkers Profiling Among Recreational Athletes A Cross Sectional Study is designed as a prospective cross sectional study with a duration of six months. A total of 61 participants will be recruited, with the sample size determined using G Power software. The aim of the study is to profile sweat based biomarkers in recreational athletes, with the objective of collecting sweat samples and analyzing them using gas chromatography mass spectrometry.

The study is justified on the basis that very few investigations have focused on sweat biomarkers in recreational athletes in India. Current approaches rely largely on invasive sampling methods such as blood or urine, which limit real time monitoring. Sweat analysis provides a non invasive alternative that can offer valuable insights. Additionally, there is a gap in literature on recreational athletes aged 18 to 28 years, which this study seeks to address.

The study will be conducted jointly by the Department of Physiotherapy, Manipal College of Health Professions, and the Department of Biotechnology, Manipal Institute of Technology, under Manipal Academy of Higher Education. Participants will be men and women aged 18 to 28 years who have been engaged in structured training at least three to five days per week for the last three months, with training sessions lasting more than 60 minutes and including aerobic, anaerobic, strength or skill based exercises. Individuals with cardiovascular, respiratory or neurological conditions, recent musculoskeletal injury, active pain, or illness that may worsen with exercise will be excluded.

Sweat collection will be performed using sterile patches placed on the forearm both before and after a shuttle run test. The samples will be transported under controlled conditions and analyzed using GCMS in a certified laboratory. Demographic details including age, sex, height, weight and BMI will be recorded. Pre participation screening with PARQ 2024 plus will be conducted, and vitals such as heart rate, blood pressure, oxygen saturation and perceived exertion will be monitored. Additional tools include bioelectrical impedance analysis for body composition and pulse oximetry.

Outcome measures will include electrolytes such as sodium, calcium, potassium and chloride, metabolites such as lactate, glucose and urea, hormonal markers like cortisol, as well as neuropeptides and cytokines. Statistical analysis will be carried out using Jamovi software, with Shapiro Wilk test and descriptive statistics applied to the biomarker data. Results will be reported in SI units. The study does not require external funding and will be supported with existing laboratory resources.

 
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