| CTRI Number |
CTRI/2024/04/065114 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
changes in heart rate variability anthropometry and cognition during 7 days of Therapeutic Naturopathic Fasting in healthy students an experimental study |
|
Scientific Title of Study
|
Autonomic variations changes in body composition and attention at different stages during 7 days of Therapeutic Naturopathic Fasting in healthy students an experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi B S |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
The school of yoga and naturopathic medicine
Swami vivekananda yoga anusandhana kendra
Department of naturopathy
Division diet and nutrition
First floor room number 08
Jigini
Bangalore
The school of yoga and naturopathic medicine
Swami vivekananda yoga anusandhana kendra
Department of naturopathy
Division diet and nutrition
First floor room number 08
Jigini
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9480542681 |
| Fax |
|
| Email |
dr.swathinutridiet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi B S |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
The school of yoga and naturopathic medicine
Swami vivekananda yoga anusandhana kendra
Department of naturopathy
Division diet and nutrition
First floor room number 08
Jigini
Bangalore
The school of yoga and naturopathic medicine
Swami vivekananda yoga anusandhana kendra
Department of naturopathy
Division diet and nutrition
First floor room number 08
Jigini
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9480542681 |
| Fax |
|
| Email |
dr.swathinutridiet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi B S |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor |
| Address |
The school of yoga and naturopathic medicine
Swami vivekananda yoga anusandhana kendra
Department of naturopathy
Division diet and nutrition
First floor room number 08
Jigini
Bangalore
TThe school of yoga and naturopathic medicine
Swami vivekananda yoga anusandhana kendra
Department of naturopathy
Division diet and nutrition
First floor room number 08
Jigini
Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9480542681 |
| Fax |
|
| Email |
dr.swathinutridiet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami vivekananda yoga anusandhana kendra
Jigani Bingipura
Bangalore district
Karnataka state
India
560105 |
|
|
Primary Sponsor
|
| Name |
Swami vivekananda yoga anusandhana kendra |
| Address |
Swami vivekananda yoga anusandhana kendra
Jigani Bingipura
Bangalore district
Karnataka state
India
560105 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Swathi B S |
Swami vivekananda yoga anusandhana kendra |
Jigani
Bingipura
Bangalore district
Karnataka state
560105
Bangalore
KARNATAKA |
9480542681
dr.swathinutridiet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami vivekananda yoga anusandhana samsthana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY HUMAN VOLUNTEERS
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no comparision since it is a single arm design |
no comparision since it is a single arm design |
| Intervention |
Therapeutic naturopathic fasting |
Fasting will be conducted for duration of 7 days
On day one raw diet will be provided and gradually shifted to only juices 5 times a day for 5 days and 7th day subjects will be brought back to normal diet gradually |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Healthy students of age group 22-26 years
Both genders will be included
Students who are willing to participate in the study
healthy volunteers
|
|
| ExclusionCriteria |
| Details |
Any systemic diseases or illness
Recent surgeries
Any medications
If they are involved in fasting or calorie restricted diet for last 6 months
Females will be excluded if they are in their menstrual cycle during the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability HRV |
total 4 timepoints
pre assessment
on 4th day
on 6th day and
post assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometry
Body composition
Perceived Stress Scale
Mindfulness attention awareness scale
State Trait anxiety Inventory
Food craving questionnaire trait
Food craving questionnaire state
Yale food addiction scale
Six-Letter cancellation test
|
3 time points
pre assessment
on 4th day
on 7th day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Fasting or abstinence from food or
drink or both are done for health,
ritualistic, religious purposes. The abstention may be complete or partial, lengthy, of short duration,
or intermittent.
Fasting has been used therapeutically since at least
the 5th century BCE, when Greek physician Hippocrates recommended
abstinence from food or drink for patients who exhibited certain symptoms of
illness. Fasting was used as a treatment and as a form of disease prevention.
Periods of fasting with restriction of solid food intake are practiced
worldwide, mostly based on traditional, cultural or religious reasons. There are no studies which includes fair number of
subjects & which explains effects about the actual therapeutic naturopathic
fasting. Hence this study is done to identify the biochemical changes during therapeutic naturopathic fasting.
Aim is to identify the effect of therapeutic naturopathic
fasting on Autonomic variations, body
composition and attention in healthy
volunteers.
Objectives are to identify the effect of therapeutic naturopathic
fasting on autonomic variables
(HRV), on
Body composition, on anthropometry, on stress & anxiety, mon
food cravings, on attention & concentration Subjects are of age group of 22-26 years Sample size: N=45,
calculated
through G power- for psychological & anthropometric analysis Study
design: Single-arm pre-post experimental design. Duration: 7 days |