| CTRI Number |
CTRI/2025/03/082772 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To study the influence of oxygenated drinks vs regular drinks on short-term performance and tiredness in long-distance runners |
|
Scientific Title of Study
|
Short term effect of oxygenated nanobubbles infused drinks vs placebo drinks on performance and fatigue in endurance runners: Pre Post Design |
| 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 G Arun Maiya |
| Designation |
Dean and Professor, MCHP |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
Room No. 1, Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block
Department of Physiotherapy, Manipal College of Health Professions, Manipal
Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
arun.maiya@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Dean and Professor, MCHP |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
Room No. 1, Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block
Department of Physiotherapy, Manipal College of Health Professions, Manipal
Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
arun.maiya@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar Sinha |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
Room No. 204, second floor, division- tower 2,
Department of Physiotherapy, Manipal College of Health Professions, Manipal
Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9535679047 |
| Fax |
|
| Email |
mukesh.sinha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| IOTA Nanotechnology Private Limited, First floor, Property No. 18B, Block A1, Delhi Rohtak Road, Paschim Vihar, West, Delhi- 110033 |
|
|
Primary Sponsor
|
| Name |
IOTA Nanotechnology Private Limited |
| Address |
IOTA NANOTECHNOLOGY PRIVATE LIMITED
First Floor, Property No. 18B, Block A1, Delhi
Rohtak Road, Paschim Vihar, West ,
Delhi-110033 |
| Type of Sponsor |
Other [Private company] |
|
|
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 G Arun Maiya |
Kasturba Hospital, Manipal |
Room number 308
Floor number 3
Performance and fitness lab
Department of Physiotherapy
Division- Baliga Block
Kasturba Hospital
Madhav Nagar
Manipal
Udupi 576104
Udupi
KARNATAKA |
9845350823
arun.maiya@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Endurance runners |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oxygenated nanobubbles-infused citrus drink |
There will be 4 sessions; each session will take 30-45 minutes for four days (where, Modified Bruce protocol will be conducted in the first two days and Wingate Anaerobic Test for next two days)
Modified Bruce Protocol will be conducted at baseline then after 24 hours 250ml of Oxygenated nanobubbles-infused citrus drink will be administered and immediately after drink again Modified Bruce Protocol will be conducted.
After 24 hours Wingate Anaerobic Test will be conducted at baseline then after 24 hours 250ml of Oxygenated nanobubbles-infused citrus drink will be administered and again the Wingate Anaerobic Test will be conducted. |
| Comparator Agent |
Placebo citrus drink |
There will be 4 sessions; each session will take 30-45 minutes for four days (where, Modified Bruce protocol will be conducted in the first two days and Wingate Anaerobic Test for next two days)
Modified Bruce Protocol will be conducted at baseline then after 24 hours 250ml of Placebo citrus drink will be administered and immediately after drink again Modified Bruce Protocol will be conducted.
After 24 hours Wingate Anaerobic Test will be conducted at baseline then after 24 hours 250ml of Placebo citrus drink will be administered and again the Wingate Anaerobic Test will be conducted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
A recreational long-distance runner
Participated in at least three institutional level running events representing their institution |
|
| ExclusionCriteria |
| Details |
Any history of chronic disease that may limit their physical activity participation
Any fluid imbalance disorders or allergy to citrus for having the oxygenated nanobubble-infused soft drinks
Presence of systemic vascular or autoimmune disorders affecting the fluid balance
Any known hypertensive or cardiovascular disorders that may be exacerbated with fluid infusions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Bruce Protocol
Wingate Anaerobic Test |
Modified Bruce Protocol – will be conducted at two time points i.e. at baseline and after 24hrs (immediately after the intake of drink) for both groups- Intervention and comparison groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rating of Perceived Exertion |
Rating of Perceived Exertion will be assessed at baseline, during Modified Bruce Protocol as each stage progresses, & at the end of the test procedure for the first two days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
31/03/2025 |
| 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="1"
Months="0"
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 objective of the study is to identify the short-term effect of oxygenated nanobubble infused drink vs placebo drink on performance and fatigue in endurance runners. In the study the intervention group participants (n=20) will be consuming 250 ml of oxygenated nanobubble-infused citrus drink and control group will be consuming 250ml placebo citrus drink. The tests like Modified Bruce Protocol and Wingate Anaerobic Test will be conducted before and after the consumption of the drink. Descriptive Statistical analysis and T- test will be done to analyze the data. |