| CTRI Number |
CTRI/2025/01/079130 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Health benefits of Millets |
|
Scientific Title of Study
|
Clinical validation of traditional millet recipes (roti/dosa/khichidi) in maintaining healthy intestinal microbial flora and preventing lifestyle associated complications |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GAP181039 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya S |
| Designation |
Principal Scientist |
| Affiliation |
CSIR National Institute for Interdisciplinary Science and Technology |
| Address |
Agro-Processing and Technology Division, CSIR National Institute for Interdisciplinary Science and Technology, Industrial Estate, Pappanamcode
Thiruvananthapuram
KERALA
695019
India |
| Phone |
8606135606 |
| Fax |
|
| Email |
priyasulu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya S |
| Designation |
Principal Scientist |
| Affiliation |
CSIR National Institute for Interdisciplinary Science and Technology |
| Address |
Agro-Processing and Technology Division, CSIR National Institute for Interdisciplinary Science and Technology, Industrial Estate, Pappanamcode
Thiruvananthapuram
KERALA
695019
India |
| Phone |
8606135606 |
| Fax |
|
| Email |
priyasulu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya S |
| Designation |
Principal Scientist |
| Affiliation |
CSIR National Institute for Interdisciplinary Science and Technology |
| Address |
Agro-Processing and Technology Division, CSIR National Institute for Interdisciplinary Science and Technology, Industrial Estate, Pappanamcode
Thiruvananthapuram
KERALA
695019
India |
| Phone |
8606135606 |
| Fax |
|
| Email |
priyasulu@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSIR-National Institute for Interdisciplinary Science and Technology (NIIST),
Pappanamcode, Thiruvananthapuram, Kerala - 695019 |
| Department of Science and Technology, New Delhi - 110016 |
| Jubilee Mission Medical College and Research Institute,
Thrissur, Kerala - 680005 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
New Delhi - 110016 |
| Type of Sponsor |
Government funding agency |
|
|
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 Preethi M Shenoy |
Jubilee Mission Medical College and Research Institute |
Department of Biochemistry,
Jubilee Mission Medical College and Research Institute, Jubilee Mission PO, Thrissur-680 005
Kerala, India.
Thrissur
KERALA |
9447618470
pmsn@live.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jubilee Mission Medical College & Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal (without type II diabetes mellitus (TY2DM), Cardiovascular Disease (CVD)/hypertension, Non-alcoholic fatty liver disease (NAFLD) /hyperlipidemia) |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, (2) ICD-10 Condition: E08-E13||Diabetes mellitus, (3) ICD-10 Condition: I51||Complications and ill-defined descriptions of heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary Intervention |
Millet diet-induced changes in Gut microbiota and biomarkers in healthy individuals. |
| Intervention |
Dietary Intervention |
Millet diet-induced changes in Gut microbiota and biomarkers in individuals with selected health conditions. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group 1: Healthy volunteers -Normal (without type II diabetes mellitus (TY2DM), Cardiovascular Disease (CVD)/hypertension, Non-alcoholic fatty liver disease (NAFLD) /hyperlipidemia), Volunteers with following conditions: Group 2: type II diabetes mellitus (TY2DM)/prediabetes, Group 3: Cardiovascular Disease (CVD)/hypertension, Group 4: Non-alcoholic fatty liver disease (NAFLD) /hyperlipidemia) will be included in this study. The participants who are on medications for the above conditions will also be included. |
|
| ExclusionCriteria |
| Details |
People with severe illnesses,
People already on a millet diet,
Those with gastrointestinal symptoms and/or gastrointestinal diseases,
Pregnant or lactating females and
Those who have recently (past month) used antibiotics will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
All participants will be subjected to analysis of changes in following biomarkers in blood sample analysis before and after millet intake-
Diabetic/ prediabetic markers (Fasting Blood Sugar)
CVD biomarkers (complete lipid profile, adiponectin, C-Reactive Protein, Angiotensin Converting Enzyme activity)
Hepatic functions (Aspartate aminotransferase, Alanine transaminase, Alkaline phosphatase, Albumin, Bilirubin, Total protein, Gamma glutamyl transferase)
Analysis of the gut microflora by 16S rRNA sequencing of stool samples before and after the millet intake |
First and last day of the 3 months period of millet diet. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Beneficial effects of millets on the gut microbiome as evidenced by increase in gut microflora.
Identification of newer disease management strategies to improve patient health outcome via dietary changes. |
First and last day of the 3 months period of millet diet. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This project aims to scientifically validate the health benefits of traditional millet-based recipes in light of their potential to combat lifestyle diseases and micronutrient deficiencies, which are prevalent public health concerns globally. Recognizing the nutritional value of millets, which are gluten-free, low in glycemic index, and rich in both macro and micro-nutrients, this study proposes a clinical validation through a clinical trial with human volunteers. The objectives include selecting volunteers post-ethical clearance, preparing and analyzing the nutritional content of millet-based breakfast recipes, collecting and analyzing blood samples for markers of lifestyle diseases, and examining the gut microflora through 16-srRNA sequencing. This comprehensive approach aims to promote millets as a dietary option for preventing and managing conditions like diabetes, obesity, and cardiovascular diseases, leveraging their historical consumption dating back to 1500 BC in India and their resurgence in modern diets worldwide. |