| CTRI Number |
CTRI/2024/09/074003 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical Other (Specify) [Dietary Supplement] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Palmyra Sprouts Help Lower Blood Sugar In Prediabetics? |
|
Scientific Title of Study
|
Effect Of Palmyra Sprout Supplementation On The Fasting Blood Glucose Levels Of Prediabetic Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abinaya Devi K |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd Floor, Vidya Sudha Block, Department of Clinical Nutrition
Sri Ramachandra Institute of Higher Education and Research
No. 1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9025123045 |
| Fax |
|
| Email |
a2723034@sriher.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
V Supriya |
| Designation |
Associate Professor |
| Affiliation |
Department of Clinical Nutrition, Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd Floor, Vidya Sudha Block, Department of Clinical Nutrition
Sri Ramachnadra Institute of Higher Education and Research
No. 1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9841273715 |
| Fax |
|
| Email |
supriya.v@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
V Supriya |
| Designation |
Associate Professor |
| Affiliation |
Department of Clinical Nutrition, Sri Ramachandra Institute of Higher Education and Research |
| Address |
3rd Floor, Vidya Sudha Block, Department of Clinical Nutrition
Sri Ramachnadra Institute of Higher Education and Research
No. 1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9841273715 |
| Fax |
|
| Email |
supriya.v@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Abinaya Devi K
3rd Floor, Vidya Sudha Block, Department of Clinical Nutrition,
Sri Ramachandra Institute of Higher Education and Research,
No. 1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu - 600116 |
|
|
Primary Sponsor
|
| Name |
Abinaya Devi K |
| Address |
3rd Floor, Vidya Sudha Block, Department of Clinical Nutrition, Sri Ramachandra Institute of Higher Education and Research,
No. 1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu, 600116 |
| Type of Sponsor |
Other [Self-Funded Project] |
|
|
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 V Supriya |
Sri Ramachandra Hospital |
Outpatients Laboratory, Ground floor,
Sri Ramachandra Hospital - G block,
No.1,
Sri Ramachandra Nagar,
Porur, Chennai,
Tamil Nadu 600116 Chennai TAMIL NADU |
9841273715
supriya.v@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No supplementation provided |
The prediabetic subjects Fasting Blood Glucose level will be taken 2 times with a specific interval of 30 days. No supplementation will be provided. This data will be used to compare with the intervention group. |
| Intervention |
Palmyra Sprout Supplementation |
The Prediabetic subjects in the intervention group will be provided with 30 days of Palmyra Sprout supplementation (Powder).
The Fasting Blood Glucose levels before and after supplementation period will be taken and analysed for any changes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Individuals with Fasting blood sugar levels between 100 to 125 mg/dL, Postprandial blood sugar levels between 140 to 199 mg/dL or HbA1C levels between 5.7% to 6.4% will be included in the study.
-Willingness to comply with study procedures and follow-up visits.
-Ability to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
-Individuals with any other disease conditions will be excluded from the study.
-Vulnerable population (below 18 years of age, Pregnant women, Breastfeeding women) are excluded.
-Non-willing participants will be exempted.
-Current use of any antidiabetic medication or supplements
-Participation in another clinical trial within the last 30 days
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced fasting blood sugar levels in the intervention group |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
22/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Need For Study:-The global burden of prediabetes is substantial and growing. Enhancing prediabetes surveillance is necessary to effectively implement diabetes prevention policies and interventions. Hence, researching the effects of forgotten traditional plants like palmyra sprout to prevent diabetes can provide insights into the possibility of safer, more accessible, affordable and culturally relevant treatment options for populations worldwide.-There are very limited in vitro studies that exist on the anti-diabetic effect of palmyra sprout and most of it concludes quoting that in vivo studies are required for the same.-This research can also bridge the gap between traditional practices and modern scientific understanding.
Protocol:The Study aims to assess and evaluate the effects of Palmyra Sprout in fasting blood glucose levels of Prediabetic individuals at risk of developing Type 2 Diabetes Mellitus.The study will begin with developing and analysing the nutritional composition of Palmyra Sprout supplement. This supplement powder will be provided to 12 prediabteic subjects in Intervention group after obtaining their consent for 30 days. The supplement can be consumed by the participants by mixing either with milk or water (their choice). Approx. dosage – 25grams/ day (based on reference article). No toxicity reported as per earlier studies. The Intervention group subjects fasting blood glucose levels before and after supplementing them with palmyra sprout powder will be assessed. Meanwhile, a group of 12 prediabetic subjects in Control group will not be provided with any supplement but only their fasting blood glucose level will be assessed two times with an interval of 30 days in between.The results between the Experimental group and Control group will be compared and appropriate statistical methods will be used to conclude the study. |