| CTRI Number |
CTRI/2026/01/102078 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effects of Caffeinated Drinks on the Brain and Reaction Time |
|
Scientific Title of Study
|
Effect of caffeinated drink on cortical excitability and reaction time among healthy young adult volunteers: a blinded randomised crossover trial” |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| . |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishchay Nishkarsh |
| Designation |
MBBS Student |
| Affiliation |
AIIMS Bhopal |
| Address |
4th floor, Department of Physiology Medical College AIIMS Bhopal
Bhopal
MADHYA PRADESH
India
4th floor, Department of Physiology Medical College AIIMS, Bhopal
Bhopal
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
6204843305 |
| Fax |
|
| Email |
me01nishchay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh L wakode |
| Designation |
HOD & Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
4th floor, Department of Physiology Medical College AIIMS Bhopal
Bhopal
MADHYA PRADESH
India
4th floor, Department of Physiology Medical College AIIMS Bhopal
Bhopal
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9423446073 |
| Fax |
|
| Email |
santosh.physiology@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh L wakode |
| Designation |
HOD & Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
4th floor, Department of Physiology Medical College AIIMS Bhopal
Bhopal
MADHYA PRADESH
India
4th floor, Department of Physiology Medical College AIIMS Bhopal
Bhopal
MADHYA PRADESH
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9423446073 |
| Fax |
|
| Email |
santosh.physiology@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhopal |
| Address |
All India Institute of Medical sciences , Saket Nager Madhya Pradesh Bhopal |
| Type of Sponsor |
Government medical college |
|
|
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 Santosh L wakode |
ALL India Institute of medical sciences (AIIMS) |
Department of physiology 4th Floor Medical college AIIMS Bhopal,2020 Bhopal
Bhopal
MADHYA PRADESH |
9423446073
santosh.physiology@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhopal Institutional Human Ethics committee - Student Research (IHEC-SR)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal cortical excitability and reaction time in young healthy medical students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caffeine |
Caffeine will be administered orally in the form of a caffeinated drink at a dose of three milligram per kilogram body weight. This is considered a moderate and safe dose based on published literature. Caffeine is commonly consumed by young adults and is not associated with significant adverse effects when taken within recommended limits. All study procedures will follow the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017. Assessment of cortical excitability using single pulse transcranial magnetic stimulation will be conducted according to internationally accepted safety guidelines for use in healthy human volunteers. |
| Comparator Agent |
Decaffeinated drink |
A decaffeinated drink without added caffeine will be used as the control intervention. The drink will be similar in appearance and taste to the caffeinated drink to maintain blinding. It will be administered orally under identical conditions as the intervention drink. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Male |
| Details |
Male participants aged 18 to 29 years
Right handed individuals
Apparently healthy volunteers capable of providing written informed consent |
|
| ExclusionCriteria |
| Details |
Overweight or obese participants with body mass index more than 25
Self reported history of tobacco use in any form
History of epilepsy or seizures
Presence of metallic implants or any contraindication to transcranial magnetic stimulation
History of neuropsychiatric disorders
History of chronic debilitating illness
History of intellectual disability
History of brain trauma or brain surgery
Current or recent use of any prescription or non prescription drugs that may affect cortical excitability or caffeine metabolism |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Corticomotor excitability will be assessed using single-pulse TMS. The primary outcome will be resting motor threshold (MT). Secondary outcomes will include motor evoked potential (MEP) amplitude and MEP latency. |
Bassline to 2 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reaction time performance will be assessed by measuring simple and choice reaction time (RT), defined as the time taken by the participant to execute a mechanical response following the presentation of single and multiple visual stimuli, respectively. Error percentage will also be recorded. Reaction time will be measured using the open-access and user-friendly Computerized Reaction Time Test (Deary–Liewald Reaction Time Task). |
Bassline to 2 Month |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
02/03/2026 |
| 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 Yet Recruiting |
| 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
|
This study aims to assess the effect of a caffeinated drink on cortical excitability and reaction time in healthy young adult male volunteers. The study will be conducted using a blinded randomised crossover design among 32 participants aged 18 to 29 years. Participants will receive a caffeinated drink containing 3 mg/kg body weight and a placebo drink on two separate days, with a 1-week washout period. Cortical excitability will be evaluated using non-invasive single pulse transcranial magnetic stimulation by measuring motor threshold, and motor evoked potential parameters. Reaction time will be assessed using a validated open-access computerised reaction time test. The study hypothesises that caffeine consumption will result in measurable changes in cortical excitability and improvement in reaction time compared to the placebo condition. |