| CTRI Number |
CTRI/2024/10/075435 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the Glycemic Index of SIDKAD Flakes and Biscuits in Healthy Individuals |
|
Scientific Title of Study
|
Development of health flakes (SIDKAD) A Siddha Kayakurpam diet for diabetes and evaluating its nutritive, Anti-oxidant and Anti-inflammatory Activity funded by AYUSH |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrCAnbarasi |
| Designation |
Research Officer Siddha |
| Affiliation |
CCRS SCRI Chennai |
| Address |
1, Department of Clinical Research, Siddha Central Research Institute CCRS
Anna Hospital campus
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8754416050 |
| Fax |
|
| Email |
dranbu1208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Ananthan |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Nutrition Telangana Hyderabad |
| Address |
1, Food Chemistry division, ICMR National Institute of Nutrition
Telangana
Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9866373363 |
| Fax |
|
| Email |
ananthan.nin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Natarajan |
| Designation |
Research Officer Siddha |
| Affiliation |
CCRS Siddha Regional Research Institute Thiruvanandhapuram |
| Address |
301, Department of Clinical Research, Siddha Regional Research Institute
Central Council for Research in Siddha Poojapura Thiruvanandhapuram Kerala
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9843086050 |
| Fax |
|
| Email |
drnatarajan78@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR-National Institute of Nutrition, Ministry of Health and Family Welfare, Government of India, Telangana, Hyderabad 500007 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Siddha |
| Address |
Central Council for Research in Siddha, Ministry of AYUSH, Government of India, Tambaram Sanatorium, Chennai 600047 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 R Ananthan |
National Institute of Nutrition ICMR |
1, Food Chemistry Division, National Institute of Nutrition, Jamai Osmania
Hyderabad
TELANGANA |
9866373363
ananthan.nin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Nutrition-ICMR, Ministry of Health and Family Welfare, Telangana, Hyderabad, 500007 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with normal BMI |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference glucose |
25/50g available carbohydrate providing glucose in 125ml/250mlwater is given as reference food three times during the study period on separate occasions in-between the test foods. Capillary blood samples will be collected for the subsequent 2 hours |
| Intervention |
SIDKAD flakes and biscuit |
25/ 50 g available carbohydrate providing SIDKAD flakes and biscuits will be given to study participants as test food once on a separate day and capillary blood samples will be collected for the subsequent 2 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
BMI – 18.5 – 24.9 Kg/m2
Willing to consume the test food
No known food allergy
|
|
| ExclusionCriteria |
| Details |
Known history of Diabetes mellitus / on anti-hyperglycemic drugs
Pregnant or lactating women
Use of drugs that influence the digestion and absorption of nutrients
Not participated in any clinical trial in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic index, and GI category of the SIDKAD biscuits and flakes |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/11/2024 |
| 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="6"
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
|
The Siddha system of medicine highly recommends lifestyle
modification, especially dietary substances, for the management and prevention
of diseases. Kayakarpam is defined as lifestyle modification through routine,
seasonal routines, diet and drugs. One such diet is SIDKAD, a Siddha Kayakarpam
diet indicated for diabetes patients as well as normal individuals for preventing
diabetes. However, it is necessary to understand the blood glucose-raising potential
of SIDKAD. As there is the rise of consuming high-glycemic foods, there is
a need to explore traditional foods and its cost-effectiveness. |