| CTRI Number |
CTRI/2019/02/017763 [Registered on: 21/02/2019] Trial Registered Prospectively |
| Last Modified On: |
16/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Coffee] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to assess the effect of coffee on the ability to perform simple physical and mental exercises in healthy individuals during the post-lunch period |
|
Scientific Title of Study
|
A randomized double- blind cross-over study to assess the effect of regular and decaffeinated coffee on psychomotor performance in healthy volunteers during post-lunch period |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suganthi S |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pharmacology,
Teaching block,
New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drsugiram@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Gupta |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pharmacology,
Teaching block,
New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drgupta.pooja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suganthi S |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Pharmacology,
Teaching block,
New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drsugiram@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Suganthi S |
| Address |
Department of Pharmacology,
All India Institute of Medical Sciences,
New Delhi. |
| 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 Suganthi S |
Clinical Pharmacology laboratory |
Department of Pharmacology,
Convergence block,
AIIMS, New Delhi.
New Delhi
DELHI |
9968859563
drsugiram@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Decaffeinated coffee |
150 ml of decaffeinated coffee with caffeine content equivalent to 3-5 mg |
| Intervention |
Regular coffee |
150 ml of regular coffee with caffeine content equivalent to 100 mg |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 21-35 years
2. Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Current Smokers (Adult who have smoked at least 100 cigarettes in their lifetime and who currently smokes cigarettes)
2. H/o medication intake (especially, H/o drugs causing psychomotor impairment (anti-histamines, benzodiazepines), caffeine containing medicinal preparations, CYP1A2 inducers & inhibitors))
3. H/o cough and cold for past 1 week
4. H/o caffeine use disorder (DSM V criteria)
5. H/o any other concurrent illness (hypertension, diabetes mellitus)
6. H/o heavy coffee drinking (consuming more than 4 cups of any type of coffee, caffeinated beverages every day)
7. H/o person who have never consumed caffeinated beverages or caffeine in any form
8. Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. difference in mean critical flicker fusion frequency between regular and decaffeinated group
2. difference in average choice reaction time between regular and decaffeinated group
3. difference in mean error count in hand steadiness test between regular and decaffeinated group
|
1 hour post intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| difference in blood pressure and heart rate between regular and decaffeinated group |
1 hour post intervention |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2019 |
| Date of Study Completion (India) |
30/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Psychomotor performance of the individual including attention span, concentration has been shown to be reduced during the post-lunch period. This post-lunch dip phenomenon has been seen even if the individuals has not consumed lunch and has been linked to 12-hour harmonic in 24-hour circadian rhythm. Caffeine tablets at 3 mg/kg, when added to decaffeinated coffee, was found to increase attention span and mood of the individual during this post-lunch period. However, the effect of regular coffee of caffeine at the dose of 100 mg on critical flicker fusion test, multiple choice reaction time and hand steadiness test has not been directly studied. Hence, the present study aims to evaluate the effect of regular and decaffeinated coffee on psychomotor performance (critical flicker fusion test, multiple choice reaction time and hand steadiness test) in healthy volunteers during the post-lunch period.
|