| CTRI Number |
CTRI/2025/07/091935 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Heartfulness Meditation on Mitochondrial Function |
|
Scientific Title of Study
|
Effect of Heartfulness Meditation Practice on Mitochondrial Function: A Biochemical and Genomic Approach |
| 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 Mansee Thakur |
| Designation |
Professor and Head |
| Affiliation |
MGM School of Biomedical Sciences, MGMIHS |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769909212 |
| Fax |
|
| Email |
mansibiotech79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansee Thakur |
| Designation |
Professor and Head |
| Affiliation |
MGM School of Biomedical Sciences, MGMIHS |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769909212 |
| Fax |
|
| Email |
mansibiotech79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Amita Kirar |
| Designation |
Ph.D. Scholar |
| Affiliation |
MGM School of Biomedical Sciences, MGMIHS |
| Address |
Department of Medical Biotechnology, MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8850441290 |
| Fax |
|
| Email |
kiraramita082000@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Biomedical Sciences, MGMIHS, Kamothe, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr. Mansee Thakur |
| Address |
MGM School of Biomedical Sciences, MGMIHS, Kamothe, Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
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 Mansee Thakur |
MGM Central Research Laboratory, Department of Medical Biotechnology, MGMSBS |
Room No 1, IInd floor, MGM School of Biomedical Sciences MGMIHS Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA |
09769909212
mansibiotech79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Research on Human Subjects of MGM Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
participants (25-40 yrs) with no history of bacterial/viral/fungal infections in the past two months, no co-morbidities like diabetes, hypertension, PCOS/PCOD, etc. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
participants will be from the age group 25-40 years, healthy (with no history of bacterial/viral/fungal infections in the past two months, no co-morbidities like diabetes, hypertension, PCOS/PCOD, etc.). |
|
| ExclusionCriteria |
| Details |
Dropout meditators unwilling to continue the practice or unable to do daily practice, attend group meditation session and individual session from 3 to 4 weeks
Individuals with chronic conditions affecting mitochondrial function (e.g., diabetes, Hypertension, neurodegenerative diseases and cvd).
Participants performing other yoga and meditation like brahma kumari, mindfulness, kriya yoga, Sahaj Yog etc.
Inability to read or comprehend the consent form; subjects with medical conditions in which a blood draw would be contraindicated (e.g., severe anaemia); use of antibiotics or probiotic/prebiotic participants living outside of the country. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean Loneliness Score,
2. Mean Gratitude Score,
3. Mean Self-Consciousness Score,
4. Mean Comprehensive Intellectual Humility Score
5. Mean Well-being Score
6. Mean Burnout Score
7. Nicotinamide adenine dinucleotide (NAD/NAD+) and Cytochrome c Oxidase levels
8. Mitochondrial DNA copy number
9. Gene expression of key mitochondrial markers.
10. Mitochondrial membrane potential |
This cross-sectional observational study involves the collection of blood samples from participants at a single point in time ie. Baseline. Blood samples will be analyzed to assess specific biomarkers relevant to the study objectives. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Meditation, particularly practices like Heartfulness, has been associated with enhanced mitochondrial function, offering insights into its cellular benefits. Studies show increased ATP production in meditators, indicating more efficient energy synthesis. Additionally, reduced oxidative stress and upregulated mitochondrial gene expression suggest improved cellular resilience and regulation. These biological changes reflect better mitochondrial health, serving as a potential mechanism underlying the broad health benefits of meditation. The findings deepen our understanding of how mind-body practices impact cellular function and open avenues for integrating meditation into therapeutic strategies to promote overall well-being by targeting mitochondrial efficiency and cellular homeostasis |
After one year |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
15/08/2025 |
| 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 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
|
Mitochondrial dysfunction is increasingly recognized as a key factor in various socioeconomic and health challenges, including neurodegenerative diseases, cardiovascular disorders, and metabolic syndromes. Psychological stress, prevalent in modern society, has been linked to mitochondrial impairment, exacerbating these conditions. This research focuses on investigating the potential health benefits of yoga and meditation, particularly Heartfulness meditation, in reducing stress-induced mitochondrial dysfunction. Addressing these impacts can significantly improve public health outcomes, especially in stress-prone populations, while also easing the burden on healthcare systems. Mitochondria play a crucial role in cellular energy production, apoptosis, and managing oxidative stress. Their health is vital for maintaining overall physiological functions. Any alteration, such as mitochondrial fragmentation or oxidative damage, can lead to the progression of chronic diseases. Therefore, safeguarding mitochondrial integrity is essential for preventing and managing a wide range of diseases. Mitochondrial biogenesis and the balance between free radicals and antioxidants are also fundamental aspects of health that can be influenced by lifestyle and stress management practices. Yoga and meditation, especially Heartfulness techniques, have shown promise in enhancing mitochondrial health. These practices can reduce oxidative stress, promote DNA repair, and improve mitochondrial function through psycho-neuro-immune regulation. This study will investigate the effects of Heartfulness meditation on mitochondrial integrity through biochemical and genomic analyses, offering a scientific basis for its role in disease prevention and health promotion. Through this research, we aim to provide evidence on how regular Heartfulness meditation may improve mitochondrial function, offering a potential therapeutic intervention for stress-related disorders. The study will highlight its capacity to promote cellular health and well-being, providing valuable insights for integrating mind-body practices into public health initiatives. |