| CTRI Number |
CTRI/2024/11/077345 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [tubers supplementation] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Tuber crop consumption in post prandial blood glucose level in normal adults and impaired glucose tolerance |
|
Scientific Title of Study
|
Effect of Tuber crop consumption on Postprandial Blood Glucose
levels in Normal and Impaired Glucose Tolerance Adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Ayshwarya devi |
| Designation |
PG(student) |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research Centre |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9784688088 |
| Fax |
|
| Email |
a2723015@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.G.Gayathri |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research Centre |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9784688088 |
| Fax |
|
| Email |
gayathri.g@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M Ayshwarya devi |
| Designation |
PG(student) |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research Centre |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur,
Chennai-600116
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur,
Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9784688088 |
| Fax |
|
| Email |
a2723015@sriher.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur,G Block,
chennai-600116 |
|
|
Primary Sponsor
|
| Name |
M Ayshwarya devi |
| Address |
Sri Ramachandra Institute Of Higher Education And Research Centre,
Porur,
Chennai-600116 |
| Type of Sponsor |
Other [self funded study] |
|
|
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 |
| DRGGayathri |
Sri Ramachandra Medical Centre,G Block |
Sri Ramachandra Institute Of Higher Education And Research,department of CLINICAL NUTRITION,
Porur,
Chennai-600116
MSC CLINICAL NUTRITION
Chennai
TAMIL NADU |
9566226255
gayathri.g@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute Of Higher Education And Research,ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR Registration No: EC/NEW/INST/2023/TN/O321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No comorbidities, medications |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Healthy individuals |
Effect of tubers on normal adults(colocassia,tapioca,yam small potato,big potato,sweet potato) and glucose solution (consecutive 7 days per individual) |
| Comparator Agent |
Impaired glucose tolerance individuals |
Effect of tubers on Impaired Glucose Tolerance adults(colocassia,tapioca,yam small potato,big potato,sweet potato)and glucose solution((consecutive 7 days per individual) |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
24-40 years.
Healthy volunteers and those diagnosed with impaired tolerance.
Those who are not consuming medicine. |
|
| ExclusionCriteria |
| Details |
Subjects who are not willing to participate.
Subjects with any other comorbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of tubers(colocassia,tapioca,small potato,big potato,yam,sweet potato)to check blood glucose tolerance |
fbs,initial,15,30,60,90 and 120minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the blood glucose response of the selected tuber crops to glucose itself. |
fbs,initial,15,30,60,90 and 120minutes |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="30" |
|
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
|
To examine effect of Tuber crop consumption on Postprandial Blood Glucose levels in Normal and Impaired Glucose Tolerance Adults. To investigate the blood glucose response of Tuber crops consumption like Colocassia, Potato, Sweet potato, Yam, Tapioca in healthy and Impaired Glucose Tolerance adults and to compare the blood glucose response of the selected tuber crops to glucose itself. Subjects (Healthy volunteers and Impaired Glucose Tolerance) will be requested to consume test food or reference food (glucose) in the morning (8 am) after 10-12 hours overnight fast. Fasting blood sample will be taken at time 0. The subjects will be requested to consume the test food (Boiled tubers) with 250 ml plain water or 50g of glucose in 250ml water within 15 minutes. Further blood samples were taken at 15, 30, 60, 90 and 120 minutes after initial intake. This will be repeated for all the test foods Colocasia, Potato (small and big), Sweet potato, Yam and Tapioca (50g) for a duration of 6 days with 3 days interval |