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临床试验/CTRI/2025/10/096689
CTRI/2025/10/096689尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
Anthropometric assessment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • partcipants will normal BMI
  • self reported healthy individuals.

排除标准

  • 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.

结局指标

主要结局

Anthropometric assessment

时间窗: Baseline and after 4 weeks of intervention

Serum lipid profile

时间窗: Baseline and after 4 weeks of intervention

次要结局

  • Perceived stress scale(Pittsburgh sleep quality index)

研究者

发起方
Dr Ankitha
申办方类型
Other [Self Sponsor]
责任方
Principal Investigator
主要研究者

Dr Ankitha

Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences

研究点 (1)

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