| CTRI Number |
CTRI/2025/04/084512 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to find out propriety time of eating sweets during any time of day and its effects on blood sugar levels. |
|
Scientific Title of Study
|
To study the acute effect of eating sweet snacks in different order with meals and at different times of day on glycemic parameters in young adult males without diabetes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyam Devendrakumar Tanna |
| Designation |
Student |
| Affiliation |
All India Institute Of Medical Sciences, Rajkot |
| Address |
Department Of Physiology, All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110
Department Of Physiology, All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110
Rajkot
GUJARAT
360110
India |
| Phone |
8488817177 |
| Fax |
8488817177 |
| Email |
tannapriyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyam Devendrakumar Tanna |
| Designation |
Student |
| Affiliation |
All India Institute Of Medical. Sciences, Rajkot |
| Address |
Department Of Physiology, All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110
Department Of Physiology, All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110
Rajkot
GUJARAT
360110
India |
| Phone |
8488817177 |
| Fax |
8488817177 |
| Email |
tannapriyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyam Devendrakumar Tanna |
| Designation |
Student |
| Affiliation |
All India Institute Of Medical. Sciences, Rajkot |
| Address |
Department Of Physiology, All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110
Department Of Physiology, All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110
Rajkot
GUJARAT
360110
India |
| Phone |
8488817177 |
| Fax |
8488817177 |
| Email |
tannapriyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rajkot ,Khanderi, Para Pipaliya
,Rajkot - 360110, Gujarat |
|
|
Primary Sponsor
|
| Name |
All. India institute Of Medical Sciences, Rajkot |
| Address |
All India institute Of Medical Sciences, Rajkot, Khanderi, Para Pipaliya,
Rajkot,
Gujarat - 360110 |
| Type of Sponsor |
Government medical college |
|
|
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 Pradip Barde |
Department Of Physiology, AIIMS Rajkot |
Room no 1003, Academic Block, All India Institute Of Medical Sciences
Khanderi, Para Pipaliya-360110
Rajkot
GUJARAT |
9021416946
bardepb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), All India Institute of Medical Sciences (AIIMS), Rajkot. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
TYPE II DIABETES MELLITUS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Time Of eating Sweets During Different Meal |
sweet snack will be given One time only , Sweet will be given to the participant either before or after all meals including breakfast
, lunch and dinner and its effect on blood sugar Level will be assessed separately for each meal and each time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Heathy young adult males of 18-45 years of age
2. BMI in 18-23[9] |
|
| ExclusionCriteria |
| Details |
1. History of any metabolic disease.
2. Smokers, Alcoholics
3. history of any eating disorders, weight loss or
other special diet within the past 6 months.
4. Allergic to milk and milk products. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. effect of time of eating sweet on Blood glucose level before and after each meal
2. Heart rate variability before and after each meal |
1. Before and after each meal
2. Heart rate variability before
and after each meal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation Of changes in blood glucose level with body composition. |
once, To compare & correlate the blood glucose changes before & after meal with body composition |
|
|
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)
|
22/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
N/A |