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CTRI Number  CTRI/2024/10/076087 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 29/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring How Diet and Caffeine Affect Stress Levels in Women Aged 20-40 
Scientific Title of Study   Interrelationship between dietary habits, caffeine intake, and stress in females aged 20 - 40 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  Harshita Tiwari 
Designation  Student  
Affiliation  Dr. BMN College of Home Science 
Address  MSc Clinical Nutrition and Dietetics, Dr. BMN College of Home Science, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra, India, 400019

Mumbai
MAHARASHTRA
400019
India 
Phone  9326037297  
Fax    
Email  tiwariharshita2205@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Sanwalka  
Designation  Associate professor 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune 
Address  Hirabai Cowasji Jehangir Medical Research Institute. Block V Lower Basement Jehangir Hospital, 32 Sassoon Road, Pune Station. Pune, India, 411001.

Pune
MAHARASHTRA
411001
India 
Phone  8108009900  
Fax    
Email  neha.sanwalka@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neha Sanwalka  
Designation  Associate professor 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune 
Address  Hirabai Cowasji Jehangir Medical Research Institute. Block V Lower Basement Jehangir Hospital, 32 Sassoon Road, Pune Station. Pune, India 411001.

Pune
MAHARASHTRA
411001
India 
Phone  8108009900  
Fax    
Email  neha.sanwalka@gmail.com  
 
Source of Monetary or Material Support  
MSc Clinical Nutrition and Dietetics, Dr. BMN College of Home Science, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra, India, 400019 
 
Primary Sponsor  
Name  Harshita Tiwari 
Address  Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha Sanwalka   Dr. BMN College of Home Science  MSc Clinical Nutrition and Dietetics, Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra, India, 400019
Mumbai
MAHARASHTRA 		 8108009900

neha.sanwalka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seva Mandal Education Societys Institutional Ethical Committee (IEC) 338 R.A Kidwai Road Matunga, Mumbai 19  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1. Females aged 20 - 40 years 2. Residing in Mumbai 3. Voluntarily agrees to participate in the study  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Females aged 20 - 40 years
2. Residing in Mumbai
3. Voluntarily agrees to participate in the study
 
 
ExclusionCriteria 
Details  1. Children and males
2. Refusal to participate in the study
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Correlation Between Dietary Habits and Stress Levels: Identifying specific dietary patterns or habits associated with higher or lower perceived stress scores among females aged 20-40 years. This includes evaluating nutrient intake, meal frequency, and types of foods consumed (e.g., whole grains, processed foods, or sugar intake) and their potential impact on stress.
2. Impact of Caffeine Consumption on Stress: Establishing a relationship between caffeine intake (frequency, quantity, sources such as coffee, tea, energy drinks) and stress levels, specifically how different caffeine consumption patterns correlate with perceived stress. 		 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Subgroup Analysis Based on Demographic and Lifestyle Factors: Examining how variables like age, occupation, marital status, and physical activity levels may influence the relationship between dietary habits, caffeine intake, and stress.
2. Dietary and Lifestyle Patterns Linked to Stress Mitigation: Identifying dietary behaviors, caffeine intake patterns, and lifestyle practices that may help lower perceived stress, potentially leading to targeted dietary recommendations.
3. Guidelines for Caffeine Consumption and Dietary Adjustments: Developing preliminary dietary recommendations tailored for females in this age group to optimize caffeine intake and dietary habits as part of stress-reduction interventions. 		 4 months 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   15/11/2024 
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="7"
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   Title: Interrelationship between Dietary Habits, Caffeine Intake, and Stress in Females Aged 20-40 Years

Aim: To investigate the interrelationship between dietary habits, caffeine intake, and stress among females aged 20-40 years.

Objectives: Assess dietary habits using a structured questionnaire.
Measure caffeine intake in participants.
Evaluate self-reported stress using the Perceived Stress Scale (PSS).
Examine the correlation between dietary habits, caffeine intake, and stress levels.

Hypothesis:
Null Hypothesis: No relationship exists between dietary habits, caffeine intake, and stress levels in females aged 20-40 years.

Study Design:
Type: Cross-sectional, descriptive study

Sampling Method: Convenience sampling sample 

Size: 240 females, based on an estimated 33% stress prevalence and a 90% confidence level with a 5% margin of errorData 

Collection:
data will be collected using a structured questionnaire covering:
Demographic Information: Age, occupation, education, and income.
Dietary Habits: Assessed via structured questions.
Caffeine Intake: Measured using a semi-quantitative questionnaire on caffeine-rich foods.
Stress Levels: Assessed using the Perceived Stress Scale (PSS).

Statistical Analysis: Data will be analyzed using SPSS, employing chi-square or Fisher’s exact test for group comparisons. Spearman’s correlation will assess relationships between caffeine intake, dietary habits, and stress. Statistical significance will be set at p < 0.05.

Expected Outcome: The study aims to clarify how dietary habits and caffeine intake correlate with stress in females aged 20-40. Results are anticipated to reveal dietary and caffeine consumption patterns associated with varying stress levels, offering valuable insights that could shape dietary recommendations to support mental and physical health.
 
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