| CTRI Number |
CTRI/2024/11/076123 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Caffeine Consumption and Sleep Quality in Middle-Aged Adults (40-60 Years): A Study in Mumbai |
|
Scientific Title of Study
|
The consumption of caffeine and caffeinated beverages and its impact on sleep quality among middle-aged adults 40-60 years in Mumbai. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Areeba Sarang |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Clinical nutrition and dietetics,338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8169900376 |
| Fax |
|
| Email |
sarangareeba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Eileen Canday |
| Designation |
Head of Nutrition & Dietetics |
| Affiliation |
Sir H. N. Reliance Foundation Hospital and Research Centre |
| Address |
Dietetics department, Raja Ram Mohan Roy Rd, Prarthana Samaj, Girgaon, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA
400004
India |
| Phone |
9820203142 |
| Fax |
|
| Email |
Eileen.Canday@rfhospital.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Eileen Canday |
| Designation |
Head of Nutrition & Dietetics |
| Affiliation |
Sir H. N. Reliance Foundation Hospital and Research Centre |
| Address |
Raja Ram Mohan Roy Rd, Prarthana Samaj, Girgaon, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA
400004
India |
| Phone |
9820203142 |
| Fax |
|
| Email |
Eileen.Canday@rfhospital.org |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 |
|
|
Primary Sponsor
|
| Name |
Ms. Areeba Sarang |
| Address |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 |
| 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 |
| Areeba Sarang |
Dr. BMN College of Home Science |
338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
8169900376
sarangareeba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1.Middle-aged adults 40-60 year’s
2.Residents of Mumbai
3.Willingness to participate in the study
4.Individuals who consume caffeine or caffeinated beverages regularly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Middle-aged adults 40-60 years
2.Residents of Mumbai
3.Willingness to participate in the study
4.Individuals who consume caffeine or caffeinated beverages regularly
|
|
| ExclusionCriteria |
| Details |
1.Individuals outside the 40-60 year’s range.
2.Individuals with pre-existing medical conditions affecting sleep quality or caffeine metabolism, unless these conditions are specifically being studied.
3.Pregnant women, as caffeine consumption guidelines differ during pregnancy.
4.Individuals who do not consent to participate in the study.
5.Those who do not consume caffeine or caffeinated beverages regularly, as their inclusion may skew the results. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Correlation between caffeine intake and sleep quality.
2.Variation in sleep quality across different age groups.
|
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Impact of timing of caffeine consumption on sleep.
2.Association between types of caffeinated beverages and sleep quality |
4 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
04/11/2024 |
| 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="4"
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
|
"The consumption of caffeine and caffeinated beverages and its impact on sleep quality among middle-aged adults 40-60 years in Mumbai." The project is spearheaded by Ms. Areeba Sarang, a student of MSc in Clinical Nutrition and Dietetics, under the guidance of Dr. Eileen Canday, Head Dietician at Sir H.N. Reliance Foundation Hospital. The study is to be conducted at Dr. BMN College of Home Science over a duration of seven months. |