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临床试验/CTRI/2025/08/092228
CTRI/2025/08/092228尚未招募2 期

Effect of Raw Vegetarian Diet on Inflammatory and Immune markers and Quality of Life in Healthy Individuals: A Non-Randomised Controlled Trial

National institute of Naturopathy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月7日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
immune marker anf inflammatory markers

研究概览

简要总结

Naturopathy promotes raw vegetarian diets for health improvement and disease prevention. This is rooted in the understanding that polyphenolic compounds, such as flavonoids, found in fresh fruits and vegetables, possess anti-inflammatory properties and are potent antioxidants. Conversely, cooking processes can destroy many beneficial components like enzymes, vitamins, and certain amino acids, and can also generate mutagenic and proinflammatory substances. Modern diets, often rich in processed and animal-based foods, are associated with increased systemic inflammation and immune dysregulation, while plant-based diets, especially raw vegetarian diets, are reported to lower markers of inflammation. However, the effects of such diets, especially in the Indian population, remain underexplored**. Methods:** A non-randomized controlled clinical trial, sample size of 20 participants into two groups: an intervention group adhering to a raw vegetarian diet, and a control group maintaining their regular mixed diet. Assessments will be conducted at baseline, midpoint, and endpoint. Inflammatory Markers to be measured include High-sensitivity C-reactive protein, Interleukin, and Tumor Necrosis Factor-alpha. Immune Parameters include Total Leukocyte Count and Lymphocyte Subsets. Other parameters like lipid profile, complete blood count, physical measurements, and subjective well-being are also assessed. Appropriate Statistical analysis will be performed based on the distribution of data.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Adults aged 18 to 60 years.
  • 2.Willingness and ability to follow a raw vegetarian diet for a full 21-day period.
  • 3.Normal baseline health parameters assessed using biochemical markers in the initial screening.

排除标准

  • Those currently taking immunosuppressive or anti-inflammatory medications
  • Pregnant or lactating women
  • Individuals with known chronic diseases (e.g., diabetes, cardiovascular disease)
  • Food allergies relevant to the dietary intervention.

结局指标

主要结局

immune marker anf inflammatory markers

时间窗: Baseline (day 0) | Day 11 | Day 21 (after the end of intervention)

次要结局

  • • 36-item Short Form Survey (SF-36) to assess quality of life(• Subjective Vitality Scales to assess vitality)

研究者

发起方
National institute of Naturopathy
申办方类型
Other [Autonomous body]
责任方
Principal Investigator
主要研究者

Nivethitha L

National Institute of Naturopathy. Pune

研究点 (1)

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