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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 


 
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