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Clinical Trials/CTRI/2025/10/096689
CTRI/2025/10/096689Not yet recruitingNot Applicable

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

Dr Ankitha1 site in 1 country78 target enrollmentStarted: December 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
78
Locations
1
Primary Endpoint
Anthropometric assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • partcipants will normal BMI
  • self reported healthy individuals.

Exclusion Criteria

  • systemic illnss
  • pregnant or lactating womens
  • acute infections within past 2 weeks
  • strict vegan diet
  • unwilling to adhere to diet
  • already enrolled in another similar study.

Outcomes

Primary Outcomes

Anthropometric assessment

Time Frame: Baseline and after 4 weeks of intervention

Serum lipid profile

Time Frame: Baseline and after 4 weeks of intervention

Secondary Outcomes

  • Perceived stress scale(Pittsburgh sleep quality index)

Investigators

Sponsor
Dr Ankitha
Sponsor Class
Other [Self Sponsor]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ankitha

Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences

Study Sites (1)

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