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CTRI Number  CTRI/2025/09/095198 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 29/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on How Diet and Stress Affect Heart Health in Adults Visiting a Hospital 
Scientific Title of Study   Influence of Diet and Stress on Cardiovascular risk stratification among adults visiting tertiary care hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Andriya Shiny Passanha 
Designation  Student 
Affiliation  Manipal College of Health Professions 
Address  Department Of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095346881  
Fax    
Email  andriya.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalaivani M 
Designation  Assistant Professor Selection Grade 
Affiliation  Manipal College of Health Professions 
Address  Department Of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9791088316  
Fax    
Email  kalaivani.m@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Andriya Shiny Passanha 
Designation  Student 
Affiliation  Manipal College of Health Professions 
Address  Department Of Medical Laboratory Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095346881  
Fax    
Email  andriya.mchpmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Kasturba Hospital, Manipal, Udupi District, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Manipal Academy Of Higher Education, Manipal, Udupi District, Karnataka, India, 576104 
Type of Sponsor  Research institution 
 
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 Kanhai R Lalani  Kasturba Hospital and Kasturba Medical College, Manipal  Department of Cardiology, Kasturba Hospital and Kasturba Medical College, MAHE, Manipal, 576104
Udupi
KARNATAKA 		 9429244322

lalani.kanhai@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adults according to ICMR guidelines 20 to 59 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Adults according to ICMR guidelines 20-59 years.
Both males and females.
Voluntary participation in the study with informed consent.
Being able to read, interpret, and complete the FFQ and PSS accurately in English and Kannada. 
 
ExclusionCriteria 
Details  Individuals with diagnosed cardiovascular diseases or ongoing treatment for the same.
Pregnant or lactating women.
Participants on medication affecting lipid or glucose metabolism (e.g., statins, corticosteroids).
Inability to provide informed consent or complete the questionnaire due to cognitive or physical impairment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Food Frequency Questionnaire (FFQ)
Perceived Stress Scale (PSS)
Lipid Profile
Blood Glucose level
Echocardiogram
Electrocardiogram
Treadmill Stress test 		 At a single time point during the participant’s routine hospital visit 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
Final Enrollment numbers achieved (Total)= "256"
Final Enrollment numbers achieved (India)="256" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/09/2025 
Date of Study Completion (India) 28/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/02/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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   Cardiovascular diseases (CVDs) remain the leading cause of global mortality, with India contributing significantly to the burden. Cardiometabolic risk arises from factors such as smoking, hypertension, dyslipidemia, obesity, inflammation, poor diet, inactivity, and stress, all of which interact to elevate cardiovascular risk. Stress, through dysregulation of the Hypothalamic Pituitary Adrenal (HPA) axis and increased allostatic load, contributes to metabolic disturbances, inflammation, and a higher risk of CVD and related disorders. Dietary habits, particularly high-sugar diets and atherogenic dyslipidemia in type 2 diabetes, further aggravate cardiovascular risk, highlighting the importance of healthy eating for prevention. Against this background, the present prospective cross-sectional study aims to evaluate how dietary habits and perceived stress together affect cardiovascular risk using the Food Frequency Questionnaire (FFQ), Perceived Stress Scale (PSS), Framingham Risk Score (FRS), lipid profile, fasting blood sugar, ECG, and ECHO in 256 adults aged 20–59 years. Participants will be recruited through voluntary participation of those visiting the Kasturba Hospital for routine health checkups at the Cardiology department based on inclusion and exclusion criteria, with voluntary consent, and data will be statistically analyzed using descriptive methods, correlation, and regression in JAMOVI software. The study justifies its importance in understanding the combined impact of diet and stress on cardiac health, thereby aiding in early prevention and targeted intervention strategies. Expected outcomes include identification of high-risk dietary and stress patterns, contributing to improved hospital-based nutrition and stress management programs, with ethical approval obtained and minimal risks beyond participant burden or psychological discomfort. 
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