CTRI Number |
CTRI/2023/11/060102 [Registered on: 21/11/2023] Trial Registered Prospectively |
Last Modified On: |
28/08/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical Other (Specify) [Millet based food supplementation and nutrition education] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Role of millets in controlling diseases |
Scientific Title of Study
|
Efficacy of Millet Based Nutrition Interventions in the Management of Lifestyle Disorders (Obesity, Diabetes and Dyslipidemia) |
Trial Acronym |
NIM (Nutrition Impact of Millets) |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrTarvinder Jeet Kaur |
Designation |
Professor and Supervisor |
Affiliation |
Kurukshetra University |
Address |
Room no.115, First floor, Department of Home Science, Kurukshetra University, Kurukshetra
Kurukshetra HARYANA 136119 India |
Phone |
9992027023 |
Fax |
|
Email |
tarvin_khushi@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Samridhi Sharma |
Designation |
Research Scholar |
Affiliation |
Kurukshetra University |
Address |
Research lab, first floor, Department of Home Science, Kurukshetra University, Kurukshetra
Kurukshetra HARYANA 136119 India |
Phone |
7206318581 |
Fax |
|
Email |
samridhi.235@kuk.ac.in |
|
Details of Contact Person Public Query
|
Name |
Samridhi Sharma |
Designation |
Research Scholar |
Affiliation |
Kurukshetra University |
Address |
Research lab, first floor, Department of Home Science, Kurukshetra University, Kurukshetra
Kurukshetra HARYANA 136119 India |
Phone |
7206318581 |
Fax |
|
Email |
samridhi.235@kuk.ac.in |
|
Source of Monetary or Material Support
|
Lok Nayak Jay Prakash Hospital, Kurukshetra-136119 |
|
Primary Sponsor
|
Name |
Samridhi Sharma |
Address |
Department of Home Science, Kurukshetra University, Kurukshetra |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Tarvinder Jeet Kaur |
Department of Home Science, Kurukshetra University, Kurukshetra |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrGurpreet Singh |
Lok Nayak Jay Prakash Hospital |
Room No.414, LNJP Hospital, Bye pass road, Darra Khera, Kalyan Nagar, Thanesar, Haryana-136118 Kurukshetra HARYANA |
9812921012
drgpsinghlnjp@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
INSTITUTIONAL HUMAN ETHICS COMMITTEE (IHEC) OF KURUKSHETRA UNIVERSITY KURUKSHETRA |
Approved |
LOK NAYAK JAY PRAKASH HOSPITAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
Nutrition education and millet supplementation |
Audio visual aids, dietary counseling, millet supplementation |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Obese, diabetic and dyslipidemic subjects in the age of 20-60 years, males and females, non-dependent on statins and not suffering from any diabetes related complications like ketoacidosis, diabetic nephropathy, etc. |
|
ExclusionCriteria |
Details |
Patients suffering from renal disorders, cancer, HIV-AIDS, respiratory disorders, pneumonia, thyroid disorders, high uric acid level, tuberculosis are excluded |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study the impact of millet based nutrition interventions |
2 Years |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate anthropometric, biochemical, clinical, and dietary status of subjects |
2 years |
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
01/12/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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 study aims to study the efficacy of millet based nutrition interventions on the nutritional status of people with obesity, diabetes and dyslipidemia. The impact of millet supplementation and nutrition education on nutritional status of subjects will be assessed. The data pertaining to the nutritional status of the subjects will be collected 3 times, i.e.; before the commencement of intervention (0 days), in the middle of intervention (90 days) and at the end of intervention (180 days).
|