| CTRI Number |
CTRI/2015/05/005780 [Registered on: 18/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
15/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effects of excessive coffee consumption in BPO workers. |
|
Scientific Title of Study
|
effects of excessive coffee consumption in BPO working executives between the age group 25-40 yrs in TCS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Saiyed |
| Designation |
Student |
| Affiliation |
DR. B.M.N COLLEGE OF HOME SCIENCE |
| Address |
27/6, MUNICIPAL TRANSIT CAMP, NEAR KHATAU MILL, BYCULLA STN ROAD, MUMBAI
Mumbai
MAHARASHTRA
400011
India |
| Phone |
7718062366 |
| Fax |
|
| Email |
saiyedsana1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha sekhar |
| Designation |
guide |
| Affiliation |
DR. B.M.N COLLEGE OF HOME SCIENCE |
| Address |
338 kidwai road, bhanuben mahendra nanavati college of home science
338 kidwai road, bhanuben mahendra nanavati college of home science
Mumbai
MAHARASHTRA
400031
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sana Saiyed |
| Designation |
Student |
| Affiliation |
DR. B.M.N COLLEGE OF HOME SCIENCE |
| Address |
27/6, MUNICIPAL TRANSIT CAMP, NEAR KHATAU MILL, BYCULLA STN ROAD, MUMBAI
MAHARASHTRA
400011
India |
| Phone |
7718062366 |
| Fax |
|
| Email |
saiyedsana1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sana saiyed |
| Address |
Block no 27 room no 6 municipal transit camp near khatau mill jacob circle byculla west 400011 |
| 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 |
| Salman Shaikh |
Tinyowl |
601/A wing, Floral deck plaza, MIDC central road, MIDC Andheri east.
Mumbai
MAHARASHTRA |
9920999220
shaikhsalman496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| seva mandal educational trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
excessive coffee drinking |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Excessive coffee drinkers will be included |
|
| ExclusionCriteria |
| Details |
Individuals with chronic disorders are excluded |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Individuals consuming excessive coffee are prone to health issues in a negative and positive manner |
7 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| excessive coffee can cause good health and bad health as well |
7 month
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM: ASSESSMENT OF EXCESSIVE COFFEE CONSUMPTION IN BPO WORKING EXECUTIVES OF AGE GROUP ( 25-40yrs). HYPOTHESIS: - There may be a stimulation effect because of caffeine content present in the coffee that may affect the health either positively or negatively.
- Caffeine may enhance cognitive performance in the excess coffee consumers
OBJECTIVES:
1) To assess the nutritional status by Anthropometric measurements.
2) To assess the nutritional status by 24 hour Diet recall method on a sub sample.
3) To see the effect of intervention on the health and nutritional status .
4) To correlate the coffee consumption with body composition, body mass and nutritional
status. |