| CTRI Number |
CTRI/2025/07/091065 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out how tea drinking habits, food choices, and sleep affect stress in young adults aged 18 to 25 years. |
|
Scientific Title of Study
|
A comparative study on the dietary pattern, sleep quality, and frequency of consumption of tea and its impact on stress levels among young adults (18-25 years) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manya Verma |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7276825247 |
| Fax |
|
| Email |
manyavermaaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of the department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of the department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, Mumbai, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Manya Verma |
| Address |
Dr. BMN College of Home Science
Divya Rishi Apartment, 338, R.A. Kidwai Marg, 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 |
| Dr Rupali Sengupta |
Dr. BMN College of Home Science |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
09892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva mandal educational society institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with no diseased conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Observational study, no intervention is involved |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals with no diseased conditions |
|
| ExclusionCriteria |
| Details |
Individuals following a specific diet.
People suffering from sleep disorders.
Those on medications (sleeping pills anti-oxidant pills etc.)
Individuals with known substance abuse ( alcohol, smoking etc)
Those undergoing stress of examination or any other short term stress period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between frequency of tea consumption, dietary pattern, sleep quality, and stress levels among young adults using self-reported questionnaires. |
At the time of data collection (single assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sleep quality score measured using the Pittsburgh Sleep Quality Index (PSQI).
Perceived stress score measured using the Perceived Stress Scale (PSS-10).
Dietary habits and food frequency patterns assessed using 24-hour dietary recall and FFQ. |
At the time of data collection.
|
|
|
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)
|
01/08/2025 |
| 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
|
This cross-sectional observational study aims to assess the relationship between dietary patterns, sleep quality, and frequency of tea consumption with stress levels among young adults aged 18 to 25 years. The study will be conducted among 150 participants using stratified random sampling. Data will be collected through validated tools including the Pittsburgh Sleep Quality Index (PSQI) for sleep assessment, the Perceived Stress Scale (PSS-10) for stress levels, a 24-hour dietary recall along with a food frequency questionnaire, and a structured tea consumption questionnaire. The findings of the study may provide insights into how lifestyle behaviors influence perceived stress in young adults and help in identifying non-pharmacological stress management strategies. |