| CTRI Number |
CTRI/2023/07/055506 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Artificial Sweeteners and a Nutritive Sweetener] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the impact of sweeteners on gut microbiota & telomere length in Diabetic adults |
|
Scientific Title of Study
|
To determine the effects of Artificial sweeteners & Nutritive sweetener on the gut microbiota and its influence on the length of telomere in the adult diabetic population: Open-Labelled Prospective Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MATCHA ANGELIN |
| Designation |
Research Scholar |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRM IST |
| Address |
Department of Microbiology, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7995192837 |
| Fax |
|
| Email |
am6819@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J S Kumar |
| Designation |
Associate Dean (PG Academics) and HOD |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRM IST |
| Address |
Department of General Medicine, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840047678 |
| Fax |
|
| Email |
kumarj1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr J S Kumar |
| Designation |
Associate Dean (PG Academics) and HOD |
| Affiliation |
SRM Medical College Hospital and Research Centre, SRM IST |
| Address |
Department of General Medicine, SRM Medical College Hospital and Research Centre, SRM IST, SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840047678 |
| Fax |
|
| Email |
kumarj1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, SRM IST |
|
|
Primary Sponsor
|
| Name |
MATCHA ANGELIN |
| Address |
Department of Microbiology, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankuathur - 603203 |
| 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 |
| MATCHA ANGELIN |
SRM Medical College Hospital and Research Centre |
Department of General Medicine, Block-B, Ground Floor, Room No-04, SRM Nagar, Potheri, Kattankulathur - 603203
Kancheepuram
TAMIL NADU |
7995192837
am6819@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Artificial Sweetener (Diabetic population) |
Stevia
|
| Intervention |
Artificial Sweetener (Diabetic population) |
Sucralose |
| Comparator Agent |
No intervention (Non-diabetic population) |
No intervention |
| Intervention |
Nutritive Sweetener (Diabetic population) |
Brown Sugar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Eligible participants (age >18 years) with type 2 diabetes
The participants who accept to adhere to the dietary plan and avoid consuming other sources
of artificial sweeteners will be considered
|
|
| ExclusionCriteria |
| Details |
Patients with Type 1 Diabetes
Patients with Gestational Diabetes Mellitus
Patients with an History of non-tolerance to artificial sweeteners
Patients who consumed any artificial sweeteners prior to the study in the last 1
month
Patients with malignancy, or had undergone chemo radio therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Artificial sweeteners, may alter the Gut Microbiota. |
0 to 8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Artificial sweeteners may modulate the length of telomere |
0 to 8 months |
|
|
Target Sample Size
|
Total Sample Size="232"
Sample Size from India="232"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open-labelled prospective randomized controlled trial with a Control group as non-diabetic population. Participants in the intervention group will be randomly assigned to one of the three arms – Arm 1 will receive Sucralose, Arm 2 will receive Stevia, and Arm 3 will receive brown sugar. The participants in the intervention group will consume the assigned sweetener for 28 weeks, whereas the participants in the control group will continue their usual diet. The participant’s gut microbiota and telomere length will be measured at baseline, after 2 weeks, and after 26 weeks. The study will involve collecting stool samples and blood samples from the participants. The stool samples will be used to analyze the gut microbiota, and the blood samples will be used to measure telomere length. |