| CTRI Number |
CTRI/2025/08/092228 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
How does eating a raw vegetarian diet for 21 days impact health in healthy individuals |
|
Scientific Title of Study
|
Effect of Raw Vegetarian Diet on Inflammatory and Immune markers and Quality of Life in Healthy Individuals: A Non-Randomised 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 |
Nivethitha L |
| Designation |
Professor |
| Affiliation |
National Institute of Naturopathy. Pune |
| Address |
National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048
Pune
MAHARASHTRA
411048
India |
| Phone |
08496930190 |
| Fax |
|
| Email |
dr.nivethitha@gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Naresh |
| Designation |
Research officer |
| Affiliation |
National Institute of Naturopathy. Pune |
| Address |
#2, Department of research and development, Admin block, National institute of naturopathy, pune-48. India
Pune
MAHARASHTRA
411048
India |
| Phone |
9976157398 |
| Fax |
|
| Email |
dr.nareshro@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Naresh |
| Designation |
Research officer |
| Affiliation |
National Institute of Naturopathy. Pune |
| Address |
#2, Department of research and development, Admin block, National institute of naturopathy, pune-48. India
Pune
MAHARASHTRA
411048
India |
| Phone |
9976157398 |
| Fax |
|
| Email |
dr.nareshro@gov.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Naturopathy, Nisarg gram, Pune, 411048, India |
|
|
Primary Sponsor
|
| Name |
National institute of Naturopathy |
| Address |
National Institute of Naturopathy, Ministry of AYUSH, Nisarg gram, yewalewadi, Pune, Maharashtra, 411048 |
| Type of Sponsor |
Other [Autonomous body] |
|
|
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 Nivethitha L |
National institute of Naturopathy |
#4, Department of womens health and child care, Maternity block, National institute of naturopathy, pune-48. India
Pune
MAHARASHTRA |
08496930190
dr.nivethitha@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC NIN, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Raw Diet |
The intervention group will follow a structured raw vegetarian diet repeated weekly over the 21-day study period. Each day begins with a specific detoxifying drink early in the morning, including soaked herbal waters or fresh juices such as ash gourd or lemon-honey. The breakfast (8–9 AM) includes hydrating foods like coconut pieces and dates, along with soaked nuts, seeds, or legumes (e.g., peanuts, almonds, walnuts, moong, and mixed seeds), accompanied by a fresh fruit such as a banana, apple, or pear. Lunch (12–1 PM) consists of varied combinations of raw vegetables like cucumber, carrot, beetroot, spinach, and onions, often paired with soaked legumes (e.g., green moong, chana, peanuts) and seasoned with lemon juice, cumin, black pepper, and occasionally honey. Mid-afternoon (3 PM) includes light, hydrating drinks such as lemon-honey water or tender coconut water. The evening meal (5:30–6:30 PM) features fresh grated or chopped raw vegetables combined with soaked pulses and seeds (e.g., matki, masoor, flaxseeds), seasoned similarly to lunch. |
| Comparator Agent |
regular diet |
Regular cooked diet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
1. Those currently taking immunosuppressive or anti-inflammatory medications
2. Pregnant or lactating women
3. Individuals with known chronic diseases (e.g., diabetes, cardiovascular disease)
4. Food allergies relevant to the dietary intervention.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| immune marker anf inflammatory markers |
Baseline (day 0)
Day 11
Day 21 (after the end of intervention)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• 36-item Short Form Survey (SF-36) to assess quality of life
• Subjective Vitality Scales to assess vitality
• Pittsburgh Sleep Quality Index (PSQI) to assess quality of sleep
• Edinburgh Mental Well-being Scale (WEMWBS) to assess mental well-being
|
Baseline (day 0)
Day 11
Day 21 (after the end of intervention)
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/09/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
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. |