| CTRI Number |
CTRI/2025/03/082283 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Study on Glycemic Response of Dragon Fruit Candies |
|
Scientific Title of Study
|
GLYCEMIC RESPONSE AND STORAGE
STABILITY OF DEVELOPED FUNCTIONAL
CANDIES FROM DRAGON FRUIT BY CO-
PIGMENTING RHODODENDRON FLOWER
ANTHOCYANIN EXTRACT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Neelam Chaturvedi |
| Designation |
Associate Professor |
| Affiliation |
Banasthali Vidyapith |
| Address |
Gyan Mandir, Dept. of Food and Nutrition Banasthali Vidyapith
Tonk
RAJASTHAN
304022
India |
| Phone |
9887374534 |
| Fax |
|
| Email |
neelamchaturvedi@banasthali.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neelam Chaturvedi |
| Designation |
Associate Professor |
| Affiliation |
Banasthali Vidyapith |
| Address |
Gyan Mandir, Dept. of Food and Nutrition Banasthali Vidyapith
Tonk
RAJASTHAN
304022
India |
| Phone |
9887374534 |
| Fax |
|
| Email |
neelamchaturvedi@banasthali.in |
|
Details of Contact Person
Public Query
|
| Name |
Shivi Tyagi |
| Designation |
Research Scholar |
| Affiliation |
Banasthali Vidyapith |
| Address |
K-10, Sector 23 Sanjay Nagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201002
India |
| Phone |
9310556105 |
| Fax |
|
| Email |
shivityagi2609@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banasthali Vidyapith, Banasthali, Rajasthan, 304022 |
|
|
Primary Sponsor
|
| Name |
Shivi Tyagi |
| Address |
K-10 sector 23 Sanjay Nagar Ghaziabad- 201002 |
| 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 Neelam Chaturvedi |
RKDF DENTAL COLLEGE & RESEARCH CENTRE, BHOPAL |
Department of Dentistry, RKDF College, Bhopal, 462026
Bhopal
MADHYA PRADESH |
9887374534
neelamchaturvedi@banasthali.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.K.D.F. Dental College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy men and women aged 22-25 years.
Body Mass Index (BMI) between 18.5 to 23.5 kg/m².
No history of chronic illnesses (e.g., diabetes, cardiovascular diseases).
Normal blood pressure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional Candies Made from Dragon Fruit and Rhododendron Flower Extract |
Dose- 35g candy each, Frequency- once in every 15 minutes upto 2 hours that is-0 min, 15 min, 30 min,45 min, 60 min, Route of administration-Oral, Total duration-15 minutes interval upto 60 minutes |
| Comparator Agent |
Market available candies/praline, naughat and jellies |
Market-available sugar candies, nougat, praline, and jellies are popular confectionery treats, with sugar candies ranging from hard to chewy textures. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Men and Women aged 22-25 years
BMI between 18.5 to 23.5
Free from any treatments/medications
Normal Blood Pressure
Willing to participate
No food allergies or intolerances |
|
| ExclusionCriteria |
| Details |
Individuals with a BMI outside the range of 18.5 to 23.5 kg/m².
Pregnant or lactating women.
Individuals with chronic medical conditions, particularly those affecting blood sugar levels (e.g., diabetes, hypoglycemia, or insulin resistance).
Individuals on medications that could affect glucose metabolism (e.g., steroids, oral contraceptives, etc.).
Those who have known allergies to the study ingredients (dragon fruit or rhododendron flower extract).
Individuals who are currently using dietary supplements (especially probiotics or any other supplements affecting blood glucose).
Individuals with uncontrolled blood pressure or cardiovascular disease.
Individuals with mental health conditions or any other condition that would make it impossible for them to understand or comply with the study protocol.
Individuals who have recently participated in another clinical trial or are likely to be involved in one during the study period. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glycemic Index (GI) of Best-Developed Candies
Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption
Metric: GI calculated using Incremental Area Under the Curve (IAUC).
Glycemic Load (GL) of Best-Developed Candies
Time Point: 15, 30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days
Metric: GL calculated using GI and carbohydrate content per serving. |
Glycemic Index (GI) of Best-Developed Candies
Time Point: 15, 30, 45, 60, 90, and 120 minutes after consumption
Metric: GI calculated using Incremental Area Under the Curve (IAUC).
Glycemic Load (GL) of Best-Developed Candies
Time Point: 15,30,45, 60, 90, and 120 minutes after consumption for the period of 6 months at an interval of 14 days
Metric: GL calculated using GI and carbohydrate content per serving. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antioxidant Capacities, Sensory Characteristics, Microbial Stability, Colour Stability |
0 DAY, 15 DAY, 30 DAY, 45 DAY, 60 DAY |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
18/05/2025 |
| 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
|
This study aims to investigate the glycemic response and storage stability of functional candies developed from dragon fruit co-pigmented with rhododendron flower anthocyanin extract. The trial will evaluate the glycemic index (GI) and glycemic load (GL) of the developed candies in healthy human participants. Additionally, the shelf life and sensory qualities of the candies will be assessed under different storage conditions. The study seeks to provide insights into the health benefits of these functional candies, focusing on their antioxidant properties and their potential impact on blood sugar regulation. Participants will consume the candies, and their blood glucose levels will be monitored to determine the glycemic response. The candies physicochemical and organoleptic properties will also be analyzed throughout the storage period to assess their stability and consumer acceptability. |