| CTRI Number |
CTRI/2024/10/074864 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Grain Free Diet For Hypertension |
|
Scientific Title of Study
|
Grain Free Diet on Hypertensive Individuals - A Pilot 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 |
Ankitha Rao |
| Designation |
Intern |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Nutrition
SDM College of Naturopathy and Yogic Sciences,
College Road, Ujire, D.K., Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9481027155 |
| Fax |
|
| Email |
ankitharao122000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manohar R |
| Designation |
Medical Officer |
| Affiliation |
Kshemavana, SDM Institute of Naturopathy and Yogic Sciences |
| Address |
Medical Officer
SDM Institute of Naturopathy and Yogic Sciences
Kshemavana, Banglore
Bangalore
KARNATAKA
562123
India |
| Phone |
9663046807 |
| Fax |
|
| Email |
mo4@kshemavana.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankitha Rao |
| Designation |
Intern |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Nutrition
SDM College of Naturopathy and Yogic Sciences
College Road, Ujire, D.K., karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9481027155 |
| Fax |
|
| Email |
ankitharao122000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kshemavana, SDM Institute of Naturopathy and Yogic Sciences, Nelamangala, Bangalore, Karnataka- 562123 |
| SDM College of Naturopathy and Yogic Sciences, College Road, Ujire, D.K., Karnataka - 574240 |
|
|
Primary Sponsor
|
| Name |
Ankitha Rao |
| Address |
Department of Nutrition
SDM College of Naturopathy and Yogic Sciences, Ujire, D.K., Karnataka- 574240 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 |
| Ankitha |
Kshemavana |
Diet Section, Nandi Block
Kshemavana, SDM Institute of Naturopathy and Yogic Sciences, Nelamangala, Bangalore, Karnataka- 562123
Bangalore
KARNATAKA |
9481027155
ankitharao122000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Ujire-574240 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Grain Free Diet |
Grain Free Diet includes fresh fruits, vegetables, legumes, milk and its products, micronutrient. A balanced diet made from these components will be given for all participants. The diet will be consists of Soups, Raw salads, Boiled vegetables, Panner, Stirred Vegetables, Fruits, Fruits and Vegetables Juices. Daily 5 meals will be provided for a period of 7 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female subjects will be included in the study
2. Age group between 30 to 60 without any serious physical illnesses like tuberculosis, heart diseases would be included in the study.
3. Subjects with hypertension who is on oral anti-hypertensives.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with the age group below 30 and above 60 will be excluded from the study.
2. Subjects with complications like chronic kidney diseases and post trauma/ surgery will be excluded from the study.
3. Subjects with cardiovascular diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Pulse Rate
Pulse Pressure
Mean Arterial Pressure |
Outcomes will be checked at baseline and after 7 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Pulse Rate
Pulse Pressure
Mean Arterial Pressure |
Outcomes will be checked at 3rd day and 5th day of the intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| Date of Study Completion (India) |
20/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypertension has become a major public health issue worldwide. The main causes include sedentary lifestyle, unhealthy eating habits, smoking, etc. Diet plays a major role in managing hypertension. A grain-free diet eliminates all grains, including wheat, spelt, barley, rye, dried corn, millet, rice, and oats, as well as foods and sometimes even ingredients that are made from them. The purpose of this study is to see the effect of grain free diet on hypertension. The study is single arm study with sample size of 20 participants consisting both males and females of ages 30 years to 60 years. The intervention is for 7 day and parameters will be checked at baseline and at end. Blood pressure both Systolic and Diastolic, Pulse rate, Pulse pressure and mean arterial pressure are the parameters in this study. After collection of data, result will be drawn by using JAMOVI software and p value will be calculated. The primary outcomes will be reduction in all the parameters. Based on the results the discussion and conclusion of the study will be drawn.
|