| 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
|
|
|
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
|
|
|
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. |