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CTRI Number  CTRI/2025/10/096689 [Registered on: 30/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of plant based and animal based indo mediterranean diet compared with routine diet on health markers in healthy adults 
Scientific Title of Study   Impact of plant-based indo mediterranean diet vs. non vegetarian indo mediterranean and routine diet on health markers in healthy adults: a triple arm randomized controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankitha  
Designation  PG Schloar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Department of Diet and Nutrition Ground Floor SDM College of Naturopathy and Yogic Sciences Ujire Dakishna Kannada Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9481027155  
Fax    
Email  ankitharao122000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth Shetty 
Designation  Principal 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Principal Chamber, Room no 1, Ground Floor SDM College of Naturopathy and Yogic Sciences Ujire Dakishna Kannada Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9448252696  
Fax    
Email  drprashanth9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankitha 
Designation  PG Schloar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences 
Address  Department of Diet and Nutrition Ground Floor SDM College of Naturopathy and Yogic Sciences Ujire Dakishna Kannada Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9481027155  
Fax    
Email  ankitharao122000@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Naturopathy and Yogic Sciences, Ujire, Dakishna Kannada, Karnataka- 574240 
 
Primary Sponsor  
Name  Dr Ankitha 
Address  Ashirvad abyadi kullenje village, post shankaranaryana, kundapura taluk, udupi district, Karnataka 576227 
Type of Sponsor  Other [Self Sponsor] 
 
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 Ankitha  SDM College of Naturopathy and Yogic Sciences  Department of Diet and nutrition Ground Floor SDM College of Naturopathy and Yogic Sciences Ujire Dakshina kannada Karnataka 574240
Dakshina Kannada
KARNATAKA 
9481027155

ankitharao122000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non vegetarian indo mediterranean diet  The diet will include vegetables, fruits, healthy fats, nuts, seeds, cold pressed oils, legumes, whole grains, millets, spices, dairy products, lean animal proteins, poultry and fish. Daily 6 meals per day for 4 weeks  
Intervention  Plant based indo mediterranean diet  The diet will include vegetables, fruits, healthy fats, nuts, seeds, cold pressed oils, legumes, whole grains, millets, spices and dairy products. Daily 6 meals per day for 4 weeks  
Comparator Agent  Routine diet  The Subjects will ask to eat there normal routine diet. Daily 6 meals per day for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. partcipants will normal BMI
2. self reported healthy individuals 
 
ExclusionCriteria 
Details  1. systemic illnss
2. pregnant or lactating womens
3. acute infections within past 2 weeks
4. strict vegan diet
5. unwilling to adhere to diet
6. already enrolled in another similar study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Anthropometric assessment
Serum lipid profile 
Baseline and after 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Perceived stress scale
Pittsburgh sleep quality index 
Baseline and after 4 weeks of intervention 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   01/12/2025 
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)  Open to Recruitment 
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 trial will compare a plant-based Indo Mediterranean diet, a non vegetarian Indo Mediterranean diet, and a routine diet for 4 weeks in healthy Indian adults to evaluate effects on stress, sleep quality, anthropometry, and lipid profile. It is a randomized, triple arm, parallel group, equal allocation of 78 participants into three groups of 26 each. Where the participants will be recruited from communities in karnataka.

Based on inclusion criteria age 18 to 45 years, BMI less than or equal to 24.9 kg per meter square, males and females, willing to follow assigned diet for 4 weeks and exclusion criteria Systemic illness, pregnant or lactating, acute infection within past 2 weeks, strict vegans or unwilling to adhere to allocation.

Interventions

Group 1: Plant-based Indo Mediterranean diet emphasizing whole grains, millets, legumes, vegetables, fruits, nuts, seeds, cold pressed oils

Group 2: Non-vegetarian Indo-Mediterranean diet with Group 1 base plus lean animal proteins as egg whites, skinless chicken, fish such as sardines or mackerel or rohu or catla and avoidance of red or processed meats.

Group 3: Routine diet

The data will be collected at baseline and after 4 weeks of intervention. Anthropometry will be done by using height, weight, hip and waist circumference measured by measuring tape and standard calibrated weighing scale. For serum lipid profile 10 ml fasting blood will be collected in aseptic condition in the morning then it will be sent for analysis in NABL accredited laboratory. For stress and sleep quality the PSS 10 and PQSI questionnaires will be administered.

After the data collection all data will be entered in ms excel then it will be processed and later analysed in Jamovi software using appropriate tests.

 

 

 
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