| 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
|
|
|
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
|
|
|
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
|
|
|
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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