| CTRI Number |
CTRI/2024/05/067227 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical
Other (Specify) [Disease Specific Functional Food Formulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nutrition intervention in subjects with type 2 diabetes mellitus |
|
Scientific Title of Study
|
Cardiovascular Risk assessment and Nutritional modulation in Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puneetha P |
| Designation |
Research Scholar |
| Affiliation |
Department of studies in Food Science and Nutrition |
| Address |
Department Of Studies in Food Science and Nutrition, University of Mysore, Manasagangothri, Mysore
Mysore
KARNATAKA
570006
India |
| Phone |
7795124302 |
| Fax |
|
| Email |
puneethap.26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asna Urooj |
| Designation |
Professor and Chairperson |
| Affiliation |
Department Of Studies in Food Science and Nutrition |
| Address |
Professor and Chairperson, Department Of Studies in Food Science and Nutrition, University of Mysore, Manasagangothri, Mysore
Mysore
KARNATAKA
570006
India |
| Phone |
9448489334 |
| Fax |
|
| Email |
asnaurooj@foodsci.uni-mysore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asna Urooj |
| Designation |
Professor and Chairperson |
| Affiliation |
Department Of Studies in Food Science and Nutrition |
| Address |
Professor and Chairperson, Department Of Studies in Food Science and Nutrition, University of Mysore, Manasagangothri, Mysore
Mysore
KARNATAKA
570006
India |
| Phone |
9448489334 |
| Fax |
|
| Email |
asnaurooj@foodsci.uni-mysore.ac.in |
|
|
Source of Monetary or Material Support
|
| 1. Monetary support_ Special cell for SC ST, centenary Hall, University of Mysore, Mysore. Fellowship Order No: Vi.Gha 4/28/2018-19 Date: 18.06.2019/267 (SL No: 38)
2. Infrastructure support_ University of Mysore, Mysore |
|
|
Primary Sponsor
|
| Name |
Puneetha P |
| Address |
Department Of Studies in Food Science and Nutrition, University of Mysore, Manasagangothri, Mysore |
| 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 Asna Urooj |
University Health Center |
Room number 1, Genaral medicine, University of Mysore, Manasagangothri, Mysore
Mysore
KARNATAKA |
9448489334
asnaurooj@foodsci.uni-mysore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E110||Type 2 diabetes mellitus with hyperosmolarity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Nutritional modulation in Type 2 diabetes mellitus |
Disease specific functional food formulation will be administered with prepared formulation orally for over a period of 90 days as per daily basis. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with T2DM, who are in the age range of 25–74 years of both genders, who are attending the PHC of UOM, Mysore, will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Subjects with known cardiovascular problems, who are on anti-inflammatory drugs, with any known metabolic disorder, Subjects who are pregnant with gestational diabetes and lactating mothers, one who does not give consent?, Patients who were critically ill
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in diabetic profile such as RBS in mg/dl, FBS in mg/dl, PPBS in mg/dl and HbA1c in % |
RBS, FBS and PPBS will be tested at baseline, 4th weeks, 8th weeks & 12th weeks. HbA1c will be estimated at baseline and 12th weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in HS_CRP in mg/L, Hcy in micro mol/L, Total cholesterol in mg/dl, HDLC in mg/dl, Triglycerides in mg/dl, LDLC in mg/dl, VLDLC in mg/dl, Body composition multifrequency analyzer by using (Inbody 770) , BMI in kg/m2 & WHR in % |
will be tested or analyzed at baseline & 12th weeks. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/05/2024 |
| 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="1"
Months="0"
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
|
This is a single-arm intervention study. A total of 20 subjects of both genders who meet inclusion criteria will be recruited, and a disease-specific functional food formulation will be given orally to patients with type 2 diabetes mellitus for a period of 90 days. The clinical and metabolic outcomes of patients will be analyzed before and after the intervention. The functional food formulation was developed by using locally available ingredients, which are cost-effective and functional foods. Recruitment of the subjects will be conducted in the health center of the University of Mysore, Mysore district. The primary outcome and the secondary outcome will be measured using anthropometric measurements, biochemical parameters, clinical signs and symptoms, dietary data, and a multifrequency analyzer for body composition. |